Synthes USA HQ, Inc.: 56 FDA recall reports
Every medical device recall the FDA has published for Synthes USA HQ, Inc.. The fault, and how the agency graded it.
56Reports
1Class I
1Ongoing
2014-01-08Most recent
1 Class I on this pageClass I means the FDA judged there was a reasonable probability of serious harm or death. Check the lot numbers against anything you hold.
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.
Synthes Hand Switch - Electric Pen Drive, Part Number 05.001.012 The Synthes Electric Pen Drive is indicate
Z-0615-2014 · Class II · reported 2014-01-08 · Terminated
- Why it was recalled
- Synthes received a complaint from a customer in which the Hand Switch for the Electric Pen Drive was not labeled correctly. The "on" and "lock" labels were interchanged.
- Product
- Synthes Hand Switch - Electric Pen Drive, Part Number 05.001.012 The Synthes Electric Pen Drive is indicated for screw insertion, pin and wire replacement, cutting of bone and metal, drilling, decorticating, shaping, and smoothing of bones and teeth in a wide variety of surgical procedures, including, but not limited to general orthopaedic trauma, foot, hand, maxillofacial, neurosurgical, oral, otolaryngolical, reconstructive, and spine surgery.
- Where it went
- Worldwide Distribution - USA (nationwide) and Internationally to Mexico and Canada. .
- How much
- 290
Synthes Trochanteric Fixation Nail As part of the Synthes Trochanteric Fixation Nail (TFN) System, the TFN
Z-0474-2014 · Class II · reported 2013-12-18 · Terminated
- Why it was recalled
- Certain lots of Trochanteric Fixation Nail were distributed to the field with the incorrect labeling of the length and diameter of the nail on the packaging.
- Product
- Synthes Trochanteric Fixation Nail As part of the Synthes Trochanteric Fixation Nail (TFN) System, the TFN Nail is intended to treat stable and unstable fractures of the proximal femur.
- Where it went
- Nationwide Distribution including WA, FL, LA, TX, GA, IN, OH, CA, MI, and PA.
- How much
- 12
Synthes TomoFix Plates The Synthes J5606-C TomoFix Osteotomy System is used for open and closed wedge osteo
Z-0473-2014 · Class II · reported 2013-12-18 · Terminated
- Why it was recalled
- A labeling correction was initiated related to the Surgical Technique Guide J5606-C "TomoFix Osteotomy System" due to the potential for a surgical delay if the surgeon inserts the superior screws at a lesser angle (4 or 6 degrees) and is not aware that those angles are not present.
- Product
- Synthes TomoFix Plates The Synthes J5606-C TomoFix Osteotomy System is used for open and closed wedge osteotomies of the medial proximal tibia, lateral proximal tibia, medial and lateral distal femur, treatment of bone and joint deformities, fractures, and malalignment caused by injury or disease such as osteoarthritis.
- Where it went
- Worldwide Distribution - USA (nationwide) Canada and Mexico
- How much
- 2912
Synthes Zero-P VA Implant 7 MM Height Parallel Sterile The Synthes Zero-P VA Implant 7 MM Height Parallel S
Z-0455-2014 · Class II · reported 2013-12-11 · Terminated
- Why it was recalled
- A potential non conformance was identified with the Zero-P VA plate where the screw could back out if the blocking mechanism is not visually confirmed to properly cover the head of the screw.
- Product
- Synthes Zero-P VA Implant 7 MM Height Parallel Sterile The Synthes Zero-P VA Implant 7 MM Height Parallel Sterile is a stand alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1.
- Where it went
- Nationwide Distribution - only AZ .
- How much
- 1
Titanium Trochanteric Fixation Nail (TFN)System Intended to treat stable and unstable fractures of the prox
Z-0452-2014 · Class II · reported 2013-12-11 · Terminated
- Why it was recalled
- Two lots of Titanium Trochanteric Fixation Nail (TFN) System are missing the second bend in the nail.
- Product
- Titanium Trochanteric Fixation Nail (TFN)System Intended to treat stable and unstable fractures of the proximal femur.
- Where it went
- Nationwide Distribution including IL, CA, AZ, FL, TX, UT, VA, NY, NM, and MT.
- How much
- 17
Synthes Soft Tissue Retractor Small Extendible. Offset blade facilitates easy preparation of the epipereost
Z-0429-2014 · Class II · reported 2013-12-11 · Terminated
- Why it was recalled
- The small extendible Soft Tissue Retractor was recalled due to locking nut (clamping sleeve) malfunction.
- Product
- Synthes Soft Tissue Retractor Small Extendible. Offset blade facilitates easy preparation of the epipereosteal cavity for percutaneous plate insertion.
- Where it went
- Worldwide Distribution - USA (nationwide) and Internationally to Canada and Mexico.
- How much
- 374
Vertebroplasty Needle Kit 10g Diamond Tip Intended to be used to inject PMMA cement into vertebral bodies
Z-0410-2014 · Class II · reported 2013-12-04 · Terminated
- Why it was recalled
- Complaints were received of inconsistencies in the expiration dates shown on the packaging of the Vertebroplasty Needle Kit 10g Diamond Tip device.
- Product
- Vertebroplasty Needle Kit 10g Diamond Tip Intended to be used to inject PMMA cement into vertebral bodies during Vertebroplasty procedure.
- Where it went
- Nationwide Distribution including IN, MT, HI, and FL.
- How much
- 40
Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/1
Z-0401-2014 · Class II · reported 2013-12-04 · Terminated
- Why it was recalled
- A plate was inadvertently released to a sales consultant that was restricted for sale.
- Product
- Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER is used for buttressing multi fragmentary diatal femur fractures including: supra-condylar, intra-articular and extra articular condylar fractures, periprosthetic fractures, fractures in normal or osteopenic bone, nonunions and malunions.
- Where it went
- US Distribution in Colorado.
- How much
- 1
Synthes Tensioning Device The Synthes Osteogenesis System, MR Conditional is intended for fracture fixatio
Z-0388-2014 · Class II · reported 2013-12-04 · Terminated
- Why it was recalled
- All lots of the Synthes Tensioning Device were recalled due to the potential for the reaction fork to come loose from the main body of the device and not allow the wire to release, nor the device to apply tension.
- Product
- Synthes Tensioning Device The Synthes Osteogenesis System, MR Conditional is intended for fracture fixation (open and closed), pseudoarthrosis or non-unions of long bones, limb lengthening by epiphyseal or metaphyseal distraction, correction of bony or soft tissue deformities and correction of segmental bony or soft tissue defects in adult and pediatric patients.
- Where it went
- Nationwide Distribution.
- How much
- 369
Synthes Implant Holder for Synfix (TM)-LR the Synthes Implant Holder for Synfix (TM)-LR is a non-powered ha
Z-0405-2014 · Class II · reported 2013-12-04 · Terminated
- Why it was recalled
- Complaints were received which described the SynFix LR implant holder breaking at the interface between the implant and the holder.
- Product
- Synthes Implant Holder for Synfix (TM)-LR the Synthes Implant Holder for Synfix (TM)-LR is a non-powered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery
- Where it went
- Worldwide Distribution - USA (nationwide) and Internationally to Canada .
- How much
- 548
Synthes Titanium Cannulated Humeral Nail Intended to aid in the alignment and stabilization of humeral fra
Z-0407-2014 · Class II · reported 2013-12-04 · Terminated
- Why it was recalled
- The packaging incorrectly depicts the Synthes Titanium Cannulated Humeral Nail as a 3 distal hole nail instead of a 2 distal locking hole nail.
- Product
- Synthes Titanium Cannulated Humeral Nail Intended to aid in the alignment and stabilization of humeral fractures
- Where it went
- Worldwide Distribution - USA (nationwide) including SC, IA, NC, TX, KY, VA, AL, PA, and Internationally to Canada.
- How much
- 14
Large Buttress Compression Nut For Blade Guide Sleeve TFN The Synthes Large Buttress Compression Nut For B
Z-0387-2014 · Class II · reported 2013-12-04 · Terminated
- Why it was recalled
- The Large Buttress Compression Nut For Blade Guide Sleeve TFN was recalled because of complaints that the compression nut did not thread completely onto the blade guide sleeve and became stuck.
- Product
- Large Buttress Compression Nut For Blade Guide Sleeve TFN The Synthes Large Buttress Compression Nut For Blade Guide Sleeve TFN is intended to treat stable and unstable pertrochanteric fractures, intertrochanteric fractures, basal neck fractures, and combinations there of.
- Where it went
- US Distribution including the states of TX, PA, NY, GA, CO, IN, AI, AR, IL, MI, TN, CA, AZ, MS and VA.
- How much
- 135
Slipped Capital Femoral Epiphysis System Product Usage: Intended for fracture fixation of large bones and
Z-0408-2014 · Class II · reported 2013-12-04 · Terminated
- Why it was recalled
- There is a possibility for the Guide Wires of the Slipped Capital Femoral Epiphysis System to stick in the cannulation of the drill bit and the drill bits to break during surgery.
- Product
- Slipped Capital Femoral Epiphysis System Product Usage: Intended for fracture fixation of large bones and large bone fragments and for slipped capital femoral epiphysis, pediatric femoral neck fractures, intercondylar femur fractures and sacroiliac joint disruptions.
- Where it went
- USA Nationwide Distribution
- How much
- 166
Synthes Titanium Minimally Invasive Reduction Screw System Polyaxial Screw Body, Part Number 04.631.500 Non
Z-0395-2014 · Class II · reported 2013-12-04 · Terminated
- Why it was recalled
- This action is being initiated following a detailed investigation in response to reported complaints of post-operative locking cap loosening. Synthes has concluded that if the construct is mis-aligned during final tightening, the potential exists for locking caps to loosen post-operatively in certain situations.
- Product
- Synthes Titanium Minimally Invasive Reduction Screw System Polyaxial Screw Body, Part Number 04.631.500 Non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation.
- Where it went
- Nationwide Distribution including CA, CO, CT, FL, GA, ID, IL, IN, LA, MA, MD, MI, MN, MT, NC, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, and WI.
- How much
- 757
Synthes Material Mix (Adjustable Cervical Distractor-Right, Matrix Distractor Rack, T-PAL Spacer Remover, Impl
Z-0393-2014 · Class II · reported 2013-12-04 · Terminated
- Why it was recalled
- One material batch used for production of the affected parts of the Synthes Material Mix were mixed in with an incorrect material with a lower than specified hardness and corrosion resistance.
- Product
- Synthes Material Mix (Adjustable Cervical Distractor-Right, Matrix Distractor Rack, T-PAL Spacer Remover, Implant Inserter) Synthes Material Mix: Adjustable Cervical Distractor-Right is used to distract spine segment. Matrix Distractor Rack is used to distract the interbody disc space. T-PAL Spacer Remover is used to remove T-PAL spacer. Implant Inserter is used to insert the ProDisc implant.
- Where it went
- Worldwided Distribution: USA (nationwide) including IL, MO, TX, WA and Internationally to Canada and Switzerland.
- How much
- approximately 44
2.4 and 2.7 MM Locking Screw SLF-TPNG with T8 Stardrive Recess 12 MM Fixation of fractures, osteotomies, nonu
Z-0380-2014 · Class II · reported 2013-12-04 · Terminated
- Why it was recalled
- Specific lots of the SS 2.4mm and SS 2.7mm Locking Screw (self-tapping) due to a mislabeling issue. The SS 2.7mm Screw was labeled as SS 2.4 mm Screw.
- Product
- 2.4 and 2.7 MM Locking Screw SLF-TPNG with T8 Stardrive Recess 12 MM Fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, particularly in osteopenic bone.
- Where it went
- Nationwide Distribution including PA, CA, FL, MO, KS, IN, IL, WV, KY, LA, NM, SC, IA, TX, AZ, GA, NC, OK, NY, TN, MI, CO, and MT.
- How much
- 98
Synthes Titanium Minimally Invasive Reduction Screw System Locking Cap, Part Number 04.631.502 Non-cervical
Z-0396-2014 · Class II · reported 2013-12-04 · Terminated
- Why it was recalled
- This action is being initiated following a detailed investigation in response to reported complaints of post-operative locking cap loosening. Synthes has concluded that if the construct is mis-aligned during final tightening, the potential exists for locking caps to loosen post-operatively in certain situations.
- Product
- Synthes Titanium Minimally Invasive Reduction Screw System Locking Cap, Part Number 04.631.502 Non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation.
- Where it went
- Nationwide Distribution including CA, CO, CT, FL, GA, ID, IL, IN, LA, MA, MD, MI, MN, MT, NC, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, and WI.
- How much
- 745
Synthes Matrix Threaded Persuader Deformity is a comprehensive thoracolumbar pedical screw system designed
Z-0384-2014 · Class II · reported 2013-12-04 · Terminated
- Why it was recalled
- Synthes became aware that during a procedure using the Matrix Threaded Persuader, the Reduction Insert malfunctioned causing pieces to break off. Once there is a breakage to the Reduction Insert it will not allow the instrument to function as required.
- Product
- Synthes Matrix Threaded Persuader Deformity is a comprehensive thoracolumbar pedical screw system designed to provide flexibility biomechanical performance and a solution to complex posterior pathological challenges.
- Where it went
- Worldwide distribution: US (nationwide) and countries of Canada and Switzerland.
- How much
- 634
Synthes 4.5 mm LCP Curved Condylar Plate Intended for buttressing multifragmentary distal femur fractures.
Z-0409-2014 · Class II · reported 2013-12-04 · Terminated
- Why it was recalled
- The Synthes 4.5 mm LCP Curved Condylar Plate was recalled because a Straight Condylar Plate is etched with a Curved Condylar Plate part number.
- Product
- Synthes 4.5 mm LCP Curved Condylar Plate Intended for buttressing multifragmentary distal femur fractures.
- Where it went
- Worldwide Distribution - USA including ID, FL, TN, NY, LA and Internationally to Canada.
- How much
- 13
Synthes Spiked Washers 13.5/6.5 Spiked Washers 13.5/6.5 are intended to be used in ligament reattachment or
Z-0394-2014 · Class II · reported 2013-12-04 · Terminated
- Why it was recalled
- During a retrospective assessment, Spiked Washers 13.5/6.5 were discovered to be mislabeled as Spiked Washers 13.5/5.5.
- Product
- Synthes Spiked Washers 13.5/6.5 Spiked Washers 13.5/6.5 are intended to be used in ligament reattachment or fixation, specifically readaptation of torn or avulsed ligaments.
- Where it went
- Nationwide Distribution
- How much
- 3087
Synthes Matrix 5.5.mm Left and Right Coronal Bender Product Usage: The Matrix 5.5.mm Left and Right Coron
Z-0391-2014 · Class II · reported 2013-12-04 · Terminated
- Why it was recalled
- A complaint was received of the tips of the Matrix 5.5.mm Left and Right Coronal Bender breaking while bending a spinal rod component of the Matrix System.
- Product
- Synthes Matrix 5.5.mm Left and Right Coronal Bender Product Usage: The Matrix 5.5.mm Left and Right Coronal Bender are used together to bend the 5.5 Matrix Rods in the coronal plane, and is intended for stabilization of the thoracic, lumbar, sacral, and/or iliac spine through screw and/or hook and rod fixation.
- Where it went
- Worldwide Distribution - USA (nationwide) including GA, FL, CA, UT, IA, AZ, OH and Internationally to Canada.
- How much
- 209
3.7mm and 5.0mm Dynamic Locking Screw (DLS) Product Usage: 3.7mm and 5.0mm Dynamic Locking Screw (DLS) i
Z-0390-2014 · Class II · reported 2013-12-04 · Terminated
- Why it was recalled
- All lots of 3.7mm and 5.0mm Dynamic Locking Screw (DLS) were recalled due to complaints of breakages at the distal tip of the pin identified after successful healing and during planned removal of the device.
- Product
- 3.7mm and 5.0mm Dynamic Locking Screw (DLS) Product Usage: 3.7mm and 5.0mm Dynamic Locking Screw (DLS) in combination with Synthes Locking Compression Plates (LCP) are intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and malunions.
- Where it went
- Worldwide Distribution - USA (nationwide) and internationally to Canada.
- How much
- 40248
Synthes Soft Tissue Retractor Small Extendible Offset blade facilitates easy preparation of the epipereoste
Z-0341-2014 · Class II · reported 2013-11-27 · Terminated
- Why it was recalled
- The potential exists for the locking screw nut to break on the Soft Tissue Retractor if it is overt-tightened.
- Product
- Synthes Soft Tissue Retractor Small Extendible Offset blade facilitates easy preparation of the epipereosteal cavity for percutaneous plate insertion.
- Where it went
- Worldwide Distribution - USA (Nationwide) and Canada.
- How much
- 374
Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical Blade Synthes Titanium Trochanteric Fixation Nail
Z-0369-2014 · Class II · reported 2013-11-27 · Terminated
- Why it was recalled
- A potential exists for non conforming Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical Blades to be distributed.
- Product
- Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical Blade Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical Blade is used to treat stable and unstable fractures of the proximal femur including pertrochanteric fractures, intertrochanteric fractures, basal neck fractures, and combinations thereof. The long TFN is additionally indicated for subtrochanteric fractures, pertrochanteric fractures associated with shaft fractures, pathologic fractures (including prophylactic use) in both trochanteric and diaphyseal regions, long subtrochanteric fractures, proximal or distal non-unions, malunions, and revisions.
- Where it went
- Worldwide Distribution - USA (nationwide) and Internationally to Mexico and Canada.
- How much
- 350195
Synthes 8.5 MM Medullary Reamer Product Usage: An orthopedic manual surgical instrument is a nonpowered h
Z-0202-2014 · Class II · reported 2013-11-20 · Terminated
- Why it was recalled
- Complaints were received for intraoperative reamer head breakages which can allow for unretrieved fragments of non-implant grade material.
- Product
- Synthes 8.5 MM Medullary Reamer Product Usage: An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, bmT, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench.
- Where it went
- Worldwide Distribution: USA (Nationwide) and countries of: Canada and Mexico.
- How much
- 2979
Synthes Application Instrument Sternal Zip Flex System intended for use in primary or secondary closure/rep
Z-0114-2014 · Class II · reported 2013-11-06 · Terminated
- Why it was recalled
- When using the 1st generation Zip Fix Application Instrument it is possible to cut the implant while the tensioning trigger is being squeezed which could lead to loosening of the implant.
- Product
- Synthes Application Instrument Sternal Zip Flex System intended for use in primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion
- Where it went
- Worldwide Distribution - US (nationwide) and country of Mexico.
- How much
- 319
Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusio
Z-0014-2014 · Class II · reported 2013-10-23 · Terminated
- Why it was recalled
- A post market safety review following several customer complaints indicated additional clarification was necessary in the Midfoot Fusion Bolt Technique Guide to reduce potential for bolt back-out or migration by emphasizing the need for supplemental fixation.
- Product
- Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
- Where it went
- Nationwide Distribution, including the states of MI, PA, SC, IA, MA, CA, WI, IL, and KS.
- How much
- 62
Synthes 3.5 MM LCP(R) Distal Humerus System The Synthes 3.5 MM LCP Distal Humerus System is intended for fi
Z-2278-2013 · Class II · reported 2013-10-02 · Terminated
- Why it was recalled
- Recall is being initiated due to the part being mislabeled (Part Number 241.267 was mislabeled with Part Number 241.276).
- Product
- Synthes 3.5 MM LCP(R) Distal Humerus System The Synthes 3.5 MM LCP Distal Humerus System is intended for fixation of fractures of the distal humerus, olecranon, and ulna in adults and adolescents (12-21) in which the growth plates have fused. Specifically, distal humerus plates are indicated for intra-articular fractures, comminuted supracondylar fractures, osteotomies, malunions and non-unions of the distal humerus.
- Where it went
- Nationwide Distribution including CA,and VA. .
- How much
- 2
Synthes Oracle Spacer System Slap Hammer, Part Number 03.809.690, Lot Number 3723847 The Oracle Spacer is i
Z-2282-2013 · Class II · reported 2013-10-02 · Terminated
- Why it was recalled
- This recall is being initiated in response to complaints received where it was reported that the proximal end of the Slap Hammer broke during use.
- Product
- Synthes Oracle Spacer System Slap Hammer, Part Number 03.809.690, Lot Number 3723847 The Oracle Spacer is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion combined with supplemental fixation. The Oracle Spacer is indicated as a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a diseased vertebral body resected or excised during partial and total vertebrectomy procedures or the treatment of tumor or trauma (i.e., fracture), to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of the collapsed vertebral body. The Slap Hammer, 03.809.690, is a dual sided device with two separate attachment options. The Slap Hammer allows a user (surgeon) to remove a previously placed trial implants.
- Where it went
- Worldwide Distribution - USA including CO, PA, TN, VA, TN, WA, and internationally to Czech Republic.
- How much
- 27
Synthes Cannulated Distal Femoral Nail (Trauma Nail), Part Number 450.851S, 420MM-Sterile. Orthppedic implant
Z-2243-2013 · Class II · reported 2013-09-25 · Terminated
- Why it was recalled
- Firm discovered that a nail that was within the scope of a previous Trauma Nail recall had been distributed.
- Product
- Synthes Cannulated Distal Femoral Nail (Trauma Nail), Part Number 450.851S, 420MM-Sterile. Orthppedic implant device.
- Where it went
- US distribution to MA.
- How much
- 1
Showing the 30 most recent of 56. The rest are searchable at the FDA enforcement report database.
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.
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