thejoe
Integra LifeSciences Corporation
Integra LifeSciences Corporation: 29 FDA recall reports
Every medical device recall the FDA has published for Integra LifeSciences Corporation. The fault, and how the agency graded it.
29Reports
0Class I
0Ongoing
2016-09-21Most recent
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
Integra Meshed Dermal Regeneration Template 5 cmx 5 cm (2 in x 2in) Rx Only Meshed Integra¿ Dermal Regenerat
Z-2777-2016 · Class II · reported 2016-09-21 · Terminated
- Why it was recalled
- Integra's post QA release review of historical product release test results for Meshed IDRT products identified the Peel Strength test average result was incorrectly calculated for a single Lot (Lot 105A00324750).
- Product
- Integra Meshed Dermal Regeneration Template 5 cmx 5 cm (2 in x 2in) Rx Only Meshed Integra¿ Dermal Regeneration Template, (Integra template) is a bilayer membrane system for skin replacement. The dermal replacement layer is made of a porous matrix of fibers of cross-linked bovine tendon collagen and glycosaminoglycan (chondroitin-6-sulfate) that is manufactured with a controlled porosity and defined degradation rate. The epidermal substitute layer is made of a thin polysiloxane (silicone) layer to control moisture loss from the wound. Integra template is indicated for the postexcisional treatment of life-threatening full-thickness or deep partial-thickness thermal injuries where sufficient autograft is not available at the time of excision or not desirable due to the physiological condition of the patient. Integra template is also indicated for the repair of scar contractures when other therapies have failed or when donor sites for repair are not sufficient or desirable due to the physiological condition of the patient Manufactured by: Integra LifeSciences Corporation 311 Enterprise Drive, Plainsboro, NJ 08536 877-444-1122 USA n 609-936-5400 outside USA 866-800-7742...
- Where it went
- Nationwide Distribution to PA
- How much
- 14 packages
The MAYFIELD¿ Ultra 360 Base Unit for head positioner, one unit per package. Product Usage: This produ
Z-1084-2015 · Class II · reported 2015-02-18 · Terminated
- Why it was recalled
- Through an investigation of complaints, Integra found that there is the possibility for the locking handle mechanism of the Base Units to fail during use.
- Product
- The MAYFIELD¿ Ultra 360 Base Unit for head positioner, one unit per package. Product Usage: This product provides the ability to position and hold a patient head while the patient is in the prone, supine, lateral or park-bench and sitting positions. It is intended to be used during diagnostic examinations or surgical procedures where a rigid support between the surgical table and a headrest or skull clamp is necessary and positional freedom is required.
- Where it went
- Worldwide Distribution - US Nationwide in the states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, WY, and DC. (25 government consignees) and in the foreign countries: CANADA, ALGERIA, ARAB EMIRATES, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CHILE, CHINA, COLUMBIA, CYPRESS, DENMARK, DOMINICAN REPUBLIC, FRANCE, GERMANY, GREAT BRITAN, HONG KONG, HUNGARY, INDIA, INDONESIA, ISRAEL, ITALY, JAPAN , JORDAN, KOREA, LIBYA, MACEDONIA, MAYLASIA, MEXICO, NETHERLANDS, POLAND, PORTUGAL, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SRI LANKA, TAIWAN, THAILAND, and TURKEY.
- How much
- 1053 Units
Integra Newdeal SURFIX Fixed Angle Locking Screw 3.5mm x 22mm (catalog number 285322S) and 3.5mm x 30mm (catal
Z-1697-2014 · Class II · reported 2014-06-11 · Terminated
- Why it was recalled
- New Deal has identified through a complaint report that some 3.5 mm Diameter x 22 mm Length Surfix screws in Lot no. F626 (Catalogue No. 285322S) have been packaged and labeled as 3.5mm Diameter x 30 mm Length Surfix screws (Catalogue No. 285330S).
- Product
- Integra Newdeal SURFIX Fixed Angle Locking Screw 3.5mm x 22mm (catalog number 285322S) and 3.5mm x 30mm (catalog number 285330S). Screws are provided in different diameters and lengths and are used to anchor various sizes and shapes of bone fixation plates when treating bone fractures or reconstruction of the ankle, foot or hand.
- Where it went
- Worldwide Distribution - USA including AR, CA, NC, TX and Internationally to Austria, Chile, Denmark, Finland, France, Germany, Greece, Ireland, Italy ,Lebanon, Portugal, Russia, South Africa, Spain, Switzerland, United Arab Emirates, and United Kingdom.
- How much
- 417 units
Integra PANTA Arthrodesis Nail System. Intended for use in tibiotalocalcaneal arthrodesis and treatment of
Z-1736-2013 · Class II · reported 2013-07-24 · Terminated
- Why it was recalled
- As a result of the investigation into an adverse trend of complaints for reports of misalignment of the calcaneal or tibial screws during use of the Panta Nail Support Device, Integra has decided to issue this voluntary medical device correction. The misalignment can result in the inability to properly insert the screws into the Panta Nail and create the potential need for revision surgery.
- Product
- Integra PANTA Arthrodesis Nail System. Intended for use in tibiotalocalcaneal arthrodesis and treatment of trauma to the hindfoot and distal tibia.
- Where it went
- Worldwide Distribution-USA (nationwide) and the countries of Austria, Australia, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Ireland, Israel, Italy, Netherlands, Portugal, Russia, Saudia Arabia, South Africa, Spain and United Arab Emirates.
- How much
- 692
Ora Plug Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for
Z-1297-2013 · Class II · reported 2013-05-22 · Terminated
- Why it was recalled
- Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.
- Product
- Ora Plug Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury. Topical administration of the Absorbable Collagen Wound Dressings directly over the wound effectively controls bleeding usually within two to five minutes.
- Where it went
- Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa.
- How much
- 31,940 boxes
HeliTape Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for
Z-1294-2013 · Class II · reported 2013-05-22 · Terminated
- Why it was recalled
- Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.
- Product
- HeliTape Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury. Topical administration of the Absorbable Collagen Wound Dressings directly over the wound effectively controls bleeding usually within two to five minutes.
- Where it went
- Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa.
- How much
- 19,030 boxes
BioMend¿ Extend" Absorbable Collagen Membrane BioMend¿ Extend" Absorbable Collagen Membrane is an absorbabl
Z-1299-2013 · Class II · reported 2013-05-22 · Terminated
- Why it was recalled
- Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.
- Product
- BioMend¿ Extend" Absorbable Collagen Membrane BioMend¿ Extend" Absorbable Collagen Membrane is an absorbable, implantable material that is indicated for guided tissue regeneration procedures in periodontal defects to enhance regeneration of the periodontal apparatus.
- Where it went
- Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa.
- How much
- 20,032 boxes
Helitene Absorbable Collagen Hemostatic Sponge Helitene is indicated in surgical procedures (other than oph
Z-1290-2013 · Class II · reported 2013-05-22 · Terminated
- Why it was recalled
- Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.
- Product
- Helitene Absorbable Collagen Hemostatic Sponge Helitene is indicated in surgical procedures (other than ophthalmological and urological surgery) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.
- Where it went
- Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa.
- How much
- 14, 525 boxes
OraMem Absorbable Collagen Membrane OraMem¿ Absorbable Collagen Membrane is an absorbable, implantable mate
Z-1298-2013 · Class II · reported 2013-05-22 · Terminated
- Why it was recalled
- Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.
- Product
- OraMem Absorbable Collagen Membrane OraMem¿ Absorbable Collagen Membrane is an absorbable, implantable material that is indicated for guided tissue regeneration procedures in periodontal defects to enhance regeneration of the periodontal apparatus.
- Where it went
- Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa.
- How much
- 812 boxes
DuraGen XS Dural Regeneration Matrix DuraGen XS Dural Regenerative Matrix is an absorbable implant for repa
Z-1285-2013 · Class II · reported 2013-05-22 · Terminated
- Why it was recalled
- Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.
- Product
- DuraGen XS Dural Regeneration Matrix DuraGen XS Dural Regenerative Matrix is an absorbable implant for repair of dural defects. DuraGen XS is an easy to handle, soft, white, pliable, non-friable, porous collagen matrix. DuraGen XS is supplied sterile, non-pyrogenic, for single use in double peel packages in a variety of sizes.
- Where it went
- Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa.
- How much
- 52 boxes
NeuraWrap Nerve Protector NeuraWrap Nerve Protector is indicated for the management of peripheral nerve inj
Z-1286-2013 · Class II · reported 2013-05-22 · Terminated
- Why it was recalled
- Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.
- Product
- NeuraWrap Nerve Protector NeuraWrap Nerve Protector is indicated for the management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue.
- Where it went
- Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa.
- How much
- 954 boxes
BioMend Absorbable Collagen Membrane BioMend¿ Absorbable Collagen Membrane is an absorbable, implantable ma
Z-1301-2013 · Class II · reported 2013-05-22 · Terminated
- Why it was recalled
- Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.
- Product
- BioMend Absorbable Collagen Membrane BioMend¿ Absorbable Collagen Membrane is an absorbable, implantable material that is indicated for guided tissue regeneration procedures in periodontal defects to enhance regeneration of the periodontal apparatus.
- Where it went
- Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa.
- How much
- 32,446 boxes
Layershield Adhesion Barrier Matrix Layershield Adhesion Barrier Matrix is an absorbable implant for use as
Z-1300-2013 · Class II · reported 2013-05-22 · Terminated
- Why it was recalled
- Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.
- Product
- Layershield Adhesion Barrier Matrix Layershield Adhesion Barrier Matrix is an absorbable implant for use as an adhesion barrier for the reduction of peridural fibrosis.
- Where it went
- Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa.
- How much
- 215 boxes
NeuraGen Nerve Guide NeuraGen Nerve Guide is indicated for repair of peripheral nerve discontinuities where
Z-1287-2013 · Class II · reported 2013-05-22 · Terminated
- Why it was recalled
- Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.
- Product
- NeuraGen Nerve Guide NeuraGen Nerve Guide is indicated for repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity.
- Where it went
- Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa.
- How much
- 1,661 boxes
Absorbable Collagen Sponge Provided As Intermediate to Another Company
Z-1302-2013 · Class II · reported 2013-05-22 · Terminated
- Why it was recalled
- Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.
- Product
- Absorbable Collagen Sponge Provided As Intermediate to Another Company
- Where it went
- Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa.
- How much
- 84,460 boxes
CollaCote Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for
Z-1292-2013 · Class II · reported 2013-05-22 · Terminated
- Why it was recalled
- Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.
- Product
- CollaCote Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury. Topical administration of the Absorbable Collagen Wound Dressings directly over the wound effectively controls bleeding usually within two to five minutes.
- Where it went
- Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa.
- How much
- 32,790 boxes
Dural Graft Matrix DuraGen¿ Dural Graft Matrix is an absorbable implant for repair of dural defects. DuraG
Z-1282-2013 · Class II · reported 2013-05-22 · Terminated
- Why it was recalled
- Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.
- Product
- Dural Graft Matrix DuraGen¿ Dural Graft Matrix is an absorbable implant for repair of dural defects. DuraGen matrix is an easy to handle, soft, white, pliable, nonfriable, porous collagen matrix. DuraGen matrix is supplied sterile, nonpyrogenic, for single use in double peel packages in a variety of sizes..
- Where it went
- Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa.
- How much
- 15,607 boxes
OraTape Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for D
Z-1296-2013 · Class II · reported 2013-05-22 · Terminated
- Why it was recalled
- Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.
- Product
- OraTape Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury. Topical administration of the Absorbable Collagen Wound Dressings directly over the wound effectively controls bleeding usually within two to five minutes.
- Where it went
- Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa.
- How much
- 17,110 boxes
DuraGen Plus Dural Regeneration Matrix DuraGen Plus Adhesion Barrier Matrix is an absorbable implant for re
Z-1284-2013 · Class II · reported 2013-05-22 · Terminated
- Why it was recalled
- Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.
- Product
- DuraGen Plus Dural Regeneration Matrix DuraGen Plus Adhesion Barrier Matrix is an absorbable implant for repair and restoration of dural defects and as an adhesion barrier for the reduction of peridural fibrosis. DuraGen Plus matrix is an easy to handle, soft, white pliable, non-friable, porous, collagen matrix. DuraGen Plus matrix is supplied sterile, nonpyrogenic, for single use in double peel packages in a variety of sizes.
- Where it went
- Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa.
- How much
- 21,179 boxes
Suturable DuraGen Dural Regenerative Matrix Suturable DuraGen Dural Regenerative Matrix is an absorbable im
Z-1283-2013 · Class II · reported 2013-05-22 · Terminated
- Why it was recalled
- Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.
- Product
- Suturable DuraGen Dural Regenerative Matrix Suturable DuraGen Dural Regenerative Matrix is an absorbable implant for repair of dural defects. Suturable DuraGen is an easy to handle, soft, white, pliable, nonfriable, porous collagen matrix with a mechanically strengthened collagen component. Suturable DuraGen is supplied sterile, non-pyrogenic, for single use in double peel packages in a variety of sizes. Suturable DuraGen may be applied using either on-lay or suturing techniques depending on clinical need and surgeon preference.
- Where it went
- Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa.
- How much
- 4, 799 boxes
INSTAT - Agent, Absorbable Hemostatic, Collagen Based INSTAT MCH is recommended for use in surgical procedu
Z-1288-2013 · Class II · reported 2013-05-22 · Terminated
- Why it was recalled
- Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.
- Product
- INSTAT - Agent, Absorbable Hemostatic, Collagen Based INSTAT MCH is recommended for use in surgical procedures (other than Urological and Ophthalmological surgery) as an adjunct to hemostatis when control of bleeding by ligature or conventional procedures is ineffective or impractical.
- Where it went
- Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa.
- How much
- 17, 616 boxes
Colla Tape Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings fo
Z-1291-2013 · Class II · reported 2013-05-22 · Terminated
- Why it was recalled
- Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.
- Product
- Colla Tape Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury. Topical administration of the Absorbable Collagen Wound Dressings directly over the wound effectively controls bleeding usually within two to five minutes.
- Where it went
- Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa.
- How much
- 49,500 boxes
CollaPlug Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for
Z-1293-2013 · Class II · reported 2013-05-22 · Terminated
- Why it was recalled
- Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.
- Product
- CollaPlug Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury. Topical administration of the Absorbable Collagen Wound Dressings directly over the wound effectively controls bleeding usually within two to five minutes.
- Where it went
- Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa.
- How much
- 155,850 boxes
HeliPlug Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for
Z-1295-2013 · Class II · reported 2013-05-22 · Terminated
- Why it was recalled
- Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.
- Product
- HeliPlug Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury. Topical administration of the Absorbable Collagen Wound Dressings directly over the wound effectively controls bleeding usually within two to five minutes.
- Where it went
- Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa.
- How much
- 42,570 boxes
Helistat Absorbable Hemostatic,Collagen Based Helistat is indicated in surgical procedures (other than opht
Z-1289-2013 · Class II · reported 2013-05-22 · Terminated
- Why it was recalled
- Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.
- Product
- Helistat Absorbable Hemostatic,Collagen Based Helistat is indicated in surgical procedures (other than ophthalmological and urological surgery) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.
- Where it went
- Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa.
- How much
- 24,342 boxes
MAYFIELD Composite Series Base Unit, Model A3101, a Swivel Adaptor (A3018) is an integral component of the Ba
Z-0558-2013 · Class II · reported 2012-12-26 · Terminated
- Why it was recalled
- An investigation of an adverse trend of complaints conducted by Integra LifeSciences identified various product performance issues which could impact the functionality of the firm's Mayfield Composite Series Base Units and Mayfield Skull Clamps. In order to prevent additional complaint reports, the firm decided to recall and replace certain lot codes of the Base Units and Skull Clamps that were d
- Product
- MAYFIELD Composite Series Base Unit, Model A3101, a Swivel Adaptor (A3018) is an integral component of the Base Unit, Model A3101. The MAYFIELD Base Unit (A3101) is an operating room table accessory intended to be used to support a patient during diagnostic examination and/or surgical procedures where a rigid support between surgical table and headrest, or skull clamp is necessary, positional freedom is required and where X-ray imaging modalities will be used. A Swivel Adaptor (A3018) is an integral component of the Base Unit A3101.
- Where it went
- Nationwide Distribution including the states of AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, KY, MA, MD, MI, MN, MO, NC, NE, NJ, NM, NY, OH, OK, OR, PA TN, TX, UT, VA, WA and WI.
- How much
- 5 base units were distributed
MAYFIELD Composite Series Skull Clamps, Model A3059, 510(k) #K120633. The MAYFIELD Skull Clamps (A3059) are
Z-0559-2013 · Class II · reported 2012-12-26 · Terminated
- Why it was recalled
- An investigation of an adverse trend of complaints conducted by Integra LifeSciences identified various product performance issues which could impact the functionality of the firm's Mayfield Composite Series Base Units and Mayfield Skull Clamps. In order to prevent additional complaint reports, the firm decided to recall and replace certain lot codes of the Base Units and Skull Clamps that were d
- Product
- MAYFIELD Composite Series Skull Clamps, Model A3059, 510(k) #K120633. The MAYFIELD Skull Clamps (A3059) are indicated for use in open and percutaneous craniotomies, as well as spinal surgery when rigid skeletal fixation is necessary.
- Where it went
- Nationwide Distribution including the states of AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, KY, MA, MD, MI, MN, MO, NC, NE, NJ, NM, NY, OH, OK, OR, PA TN, TX, UT, VA, WA and WI.
- How much
- eight (8) skull clamps were distributed
Integra HRAIM Head Ring Assembly with Intubation Mounts The CRW stereotactic system is used in conjunction
Z-2429-2012 · Class II · reported 2012-09-26 · Terminated
- Why it was recalled
- T-handle screw is used on a complementary product to the CRW, the Integra HRAIM, which is the CT-compatible intubation Head Ring Assembly. When the T-handle on the HRAIM intubation hoop is tightened, the T-handle could stop in a vertical position that prevents the CRWPRECISE and certain models of the CRW-ASL from seating properly on the head ring although it appears to be fully seated
- Product
- Integra HRAIM Head Ring Assembly with Intubation Mounts The CRW stereotactic system is used in conjunction with the HRAIM head ring is a target-centered system that can be configured to be CT-only or CT/MR compatible. The CRW stereotactic system is a multi-purpose system used for localizing intercranial targets for precisely directing instruments such as: Biopsy forceps RF lesioning electrodes Deep brain electrodes Recording and stimulating electrodes
- Where it went
- Worldwide distribution: USA (Nationwide) and countries of: Argentina, Australia, Belgium, Canada, China, Czec, Denmark, France, Hong Kong, Hungary, Italy, Japan, Malaysia, Philippines, Singapore, Spain, South Africa, and UK.
- How much
- 188 units
Integra CRW Precision Arc (CRWPRECISE), CRW Arc System (CRWASL), HRAIM Head Ring Assembly with Intubation Mou
Z-2428-2012 · Class II · reported 2012-09-26 · Terminated
- Why it was recalled
- T-handle screw is used on a complementary product to the CRW, the Integra HRAIM, which is the CT-compatible intubation Head Ring Assembly. When the T-handle on the HRAIM intubation hoop is tightened, the T-handle could stop in a vertical position that prevents the CRWPRECISE and certain models of the CRW-ASL from seating properly on the head ring although it appears to be fully seated
- Product
- Integra CRW Precision Arc (CRWPRECISE), CRW Arc System (CRWASL), HRAIM Head Ring Assembly with Intubation Mounts The CRW stereotactic system is used in conjunction with the HRAIM head ring is a target-centered system that can be configured to be CT-only or CTIMR compatible. The CRW stereotactic system is a multi-purpose system used for localizing intercranial targets for precisely directing instruments such as: Biopsy forceps RF lesioning electrodes Deep brain electrodes Recording and stimulating electrodes
- Where it went
- Worldwide distribution: USA (Nationwide) and countries of: Argentina, Australia, Belgium, Canada, China, Czec, Denmark, France, Hong Kong, Hungary, Italy, Japan, Malaysia, Philippines, Singapore, Spain, South Africa, and UK.
- How much
- 175 units
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
← All device recalls