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Smith & Nephew, Inc. Endoscopy Divisio
Smith & Nephew, Inc. Endoscopy Division: 37 FDA recall reports
Every medical device recall the FDA has published for Smith & Nephew, Inc. Endoscopy Division. The fault, and how the agency graded it.
37Reports
0Class I
0Ongoing
2014-07-23Most 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.
SUTUREFIX Ultra S with 1 #2 Ultrabraid (blue) Product Code: 72203852 Fastener, fixation, nondegradable, so
Z-2047-2014 · Class II · reported 2014-07-23 · Terminated
- Why it was recalled
- Sterility of device is compromised due to breach in sterile barrier
- Product
- SUTUREFIX Ultra S with 1 #2 Ultrabraid (blue) Product Code: 72203852 Fastener, fixation, nondegradable, soft tissue
- Where it went
- Worldwide Distribution - USA (nationwide) and Internationally to Australia, Belgium, Denmark, France, Germany, Great Britain, Italy, Netherlands, Norway, Portugal, Spain, and Sweden.
- How much
- 907 units
SUTUREFIX Ultra S with 1 #2 Ultrabraid Suture (blue/white) Product Code: 72203853 Fastener, fixation, nond
Z-2048-2014 · Class II · reported 2014-07-23 · Terminated
- Why it was recalled
- Sterility of device is compromised due to breach in sterile barrier
- Product
- SUTUREFIX Ultra S with 1 #2 Ultrabraid Suture (blue/white) Product Code: 72203853 Fastener, fixation, nondegradable, soft tissue
- Where it went
- Worldwide Distribution - USA (nationwide) and Internationally to Australia, Belgium, Denmark, France, Germany, Great Britain, Italy, Netherlands, Norway, Portugal, Spain, and Sweden.
- How much
- 1086 untis
SUTUREFIX Ultra S Double Loaded Suture Product Code: 72203854 Fastener, fixation, nondegradable, soft tiss
Z-2049-2014 · Class II · reported 2014-07-23 · Terminated
- Why it was recalled
- Sterility of device is compromised due to breach in sterile barrier
- Product
- SUTUREFIX Ultra S Double Loaded Suture Product Code: 72203854 Fastener, fixation, nondegradable, soft tissue
- Where it went
- Worldwide Distribution - USA (nationwide) and Internationally to Australia, Belgium, Denmark, France, Germany, Great Britain, Italy, Netherlands, Norway, Portugal, Spain, and Sweden.
- How much
- 763 units
SUTUREFIX Ultra Anchor XL with one (#2) Ultrabraid Blue Product Code: 72203841 Fastener, fixation, nonde
Z-2045-2014 · Class II · reported 2014-07-23 · Terminated
- Why it was recalled
- Sterility of device is compromised due to breach in sterile barrier
- Product
- SUTUREFIX Ultra Anchor XL with one (#2) Ultrabraid Blue Product Code: 72203841 Fastener, fixation, nondegradable, soft tissue
- Where it went
- Worldwide Distribution - USA (nationwide) and Internationally to Australia, Belgium, Denmark, France, Germany, Great Britain, Italy, Netherlands, Norway, Portugal, Spain, and Sweden.
- How much
- 259 units
SUTUREFIX Ultra Anchor XL with one (#2) Ultrabraid Cobraid Suture Product Code: 72203842 Fastener, fixatio
Z-2046-2014 · Class II · reported 2014-07-23 · Terminated
- Why it was recalled
- Sterility of device is compromised due to breach in sterile barrier
- Product
- SUTUREFIX Ultra Anchor XL with one (#2) Ultrabraid Cobraid Suture Product Code: 72203842 Fastener, fixation, nondegradable, soft tissue
- Where it went
- Worldwide Distribution - USA (nationwide) and Internationally to Australia, Belgium, Denmark, France, Germany, Great Britain, Italy, Netherlands, Norway, Portugal, Spain, and Sweden.
- How much
- 136 units
OSTEORAPTOR 2.3 mm Suture Anchor with 1 ULTRABRAID COBRAID Suture, Black; Part Number: 72201992 Biodegrada
Z-2223-2013 · Class II · reported 2013-09-25 · Terminated
- Why it was recalled
- Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
- Product
- OSTEORAPTOR 2.3 mm Suture Anchor with 1 ULTRABRAID COBRAID Suture, Black; Part Number: 72201992 Biodegradable suture anchor
- Where it went
- Worldwide Distribution - USA (nationwide) Canada, Europe: Austria, Belgium, Cyprus, Czech Republic, Denmark, Germany, Greece, Finland, France, Italy, Ireland, Luxembourg, Netherlands, Norway, Poland, Portugal, Russia, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine and United Kingdom, Asia-pacific: Australia, China, Dubai, Hong Kong, India, Japan, Malaysia, New Zealand, Philippines, Sri Lanka, Singapore, South Korea, Taiwan, Thailand, Argentina, Bermuda, Brazil, Chile, Colombia, Costa Rica, Israel, Mexico, Puerto Rico, South Africa, and Venezuela.
- How much
- 18919
OSTEORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID Suture, White; Part Number: 72202165 Biodegradable sut
Z-2226-2013 · Class II · reported 2013-09-25 · Terminated
- Why it was recalled
- Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
- Product
- OSTEORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID Suture, White; Part Number: 72202165 Biodegradable suture anchor
- Where it went
- Worldwide Distribution - USA (nationwide) Canada, Europe: Austria, Belgium, Cyprus, Czech Republic, Denmark, Germany, Greece, Finland, France, Italy, Ireland, Luxembourg, Netherlands, Norway, Poland, Portugal, Russia, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine and United Kingdom, Asia-pacific: Australia, China, Dubai, Hong Kong, India, Japan, Malaysia, New Zealand, Philippines, Sri Lanka, Singapore, South Korea, Taiwan, Thailand, Argentina, Bermuda, Brazil, Chile, Colombia, Costa Rica, Israel, Mexico, Puerto Rico, South Africa, and Venezuela.
- How much
- 4452 US
BIORAPTOR 2.9 mm Suture Anchor Straight, pack of 2 ULTRABRAID Suture; Part Number: 72200690 Biodegradable s
Z-2218-2013 · Class II · reported 2013-09-25 · Terminated
- Why it was recalled
- Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
- Product
- BIORAPTOR 2.9 mm Suture Anchor Straight, pack of 2 ULTRABRAID Suture; Part Number: 72200690 Biodegradable suture anchor
- Where it went
- Worldwide Distribution - USA (nationwide) Canada, Europe: Austria, Belgium, Cyprus, Czech Republic, Denmark, Germany, Greece, Finland, France, Italy, Ireland, Luxembourg, Netherlands, Norway, Poland, Portugal, Russia, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine and United Kingdom, Asia-pacific: Australia, China, Dubai, Hong Kong, India, Japan, Malaysia, New Zealand, Philippines, Sri Lanka, Singapore, South Korea, Taiwan, Thailand, Argentina, Bermuda, Brazil, Chile, Colombia, Costa Rica, Israel, Mexico, Puerto Rico, South Africa, and Venezuela.
- How much
- 725 US
OSTEORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture, White / Black; Part Number: 72201996 Biodegrada
Z-2225-2013 · Class II · reported 2013-09-25 · Terminated
- Why it was recalled
- Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
- Product
- OSTEORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture, White / Black; Part Number: 72201996 Biodegradable suture anchor
- Where it went
- Worldwide Distribution - USA (nationwide) Canada, Europe: Austria, Belgium, Cyprus, Czech Republic, Denmark, Germany, Greece, Finland, France, Italy, Ireland, Luxembourg, Netherlands, Norway, Poland, Portugal, Russia, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine and United Kingdom, Asia-pacific: Australia, China, Dubai, Hong Kong, India, Japan, Malaysia, New Zealand, Philippines, Sri Lanka, Singapore, South Korea, Taiwan, Thailand, Argentina, Bermuda, Brazil, Chile, Colombia, Costa Rica, Israel, Mexico, Puerto Rico, South Africa, and Venezuela.
- How much
- 5873 US
TWINFIX Ultra 5.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (blue, blue-COBRAID) with Needles; P
Z-2239-2013 · Class II · reported 2013-09-25 · Terminated
- Why it was recalled
- Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
- Product
- TWINFIX Ultra 5.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (blue, blue-COBRAID) with Needles; Part Number: 72202616 Biodegradable suture anchor
- Where it went
- Worldwide Distribution - USA (nationwide) Canada, Europe: Austria, Belgium, Cyprus, Czech Republic, Denmark, Germany, Greece, Finland, France, Italy, Ireland, Luxembourg, Netherlands, Norway, Poland, Portugal, Russia, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine and United Kingdom, Asia-pacific: Australia, China, Dubai, Hong Kong, India, Japan, Malaysia, New Zealand, Philippines, Sri Lanka, Singapore, South Korea, Taiwan, Thailand, Argentina, Bermuda, Brazil, Chile, Colombia, Costa Rica, Israel, Mexico, Puerto Rico, South Africa, and Venezuela.
- How much
- 2038 US
OSTEORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture, White / Blue ; Part Number: 72201995 Biodegrada
Z-2221-2013 · Class II · reported 2013-09-25 · Terminated
- Why it was recalled
- Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
- Product
- OSTEORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture, White / Blue ; Part Number: 72201995 Biodegradable suture anchor
- Where it went
- Worldwide Distribution - USA (nationwide) Canada, Europe: Austria, Belgium, Cyprus, Czech Republic, Denmark, Germany, Greece, Finland, France, Italy, Ireland, Luxembourg, Netherlands, Norway, Poland, Portugal, Russia, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine and United Kingdom, Asia-pacific: Australia, China, Dubai, Hong Kong, India, Japan, Malaysia, New Zealand, Philippines, Sri Lanka, Singapore, South Korea, Taiwan, Thailand, Argentina, Bermuda, Brazil, Chile, Colombia, Costa Rica, Israel, Mexico, Puerto Rico, South Africa, and Venezuela.
- How much
- 17696 US
OSTEORAPTOR CURVED 2.3 mm Suture Anchor SA ULTRABRAID COBRAID Suture, Blue; Part Number: 72203290 Biodegra
Z-2228-2013 · Class II · reported 2013-09-25 · Terminated
- Why it was recalled
- Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
- Product
- OSTEORAPTOR CURVED 2.3 mm Suture Anchor SA ULTRABRAID COBRAID Suture, Blue; Part Number: 72203290 Biodegradable suture anchor
- Where it went
- Worldwide Distribution - USA (nationwide) Canada, Europe: Austria, Belgium, Cyprus, Czech Republic, Denmark, Germany, Greece, Finland, France, Italy, Ireland, Luxembourg, Netherlands, Norway, Poland, Portugal, Russia, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine and United Kingdom, Asia-pacific: Australia, China, Dubai, Hong Kong, India, Japan, Malaysia, New Zealand, Philippines, Sri Lanka, Singapore, South Korea, Taiwan, Thailand, Argentina, Bermuda, Brazil, Chile, Colombia, Costa Rica, Israel, Mexico, Puerto Rico, South Africa, and Venezuela.
- How much
- 10296 US
TWINFIX" Ultra PLLA/HA 6.5 mm with 2 ULTRABRAID" Suture, White / Black: Part Number: 72202608 Biodegradable
Z-2235-2013 · Class II · reported 2013-09-25 · Terminated
- Why it was recalled
- Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
- Product
- TWINFIX" Ultra PLLA/HA 6.5 mm with 2 ULTRABRAID" Suture, White / Black: Part Number: 72202608 Biodegradable suture anchor
- Where it went
- Worldwide Distribution - USA (nationwide) Canada, Europe: Austria, Belgium, Cyprus, Czech Republic, Denmark, Germany, Greece, Finland, France, Italy, Ireland, Luxembourg, Netherlands, Norway, Poland, Portugal, Russia, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine and United Kingdom, Asia-pacific: Australia, China, Dubai, Hong Kong, India, Japan, Malaysia, New Zealand, Philippines, Sri Lanka, Singapore, South Korea, Taiwan, Thailand, Argentina, Bermuda, Brazil, Chile, Colombia, Costa Rica, Israel, Mexico, Puerto Rico, South Africa, and Venezuela.
- How much
- 1308 US
OSTOSTEORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID COBRAID Suture, Blue; Part Number: 72201994 Biodegra
Z-2224-2013 · Class II · reported 2013-09-25 · Terminated
- Why it was recalled
- Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
- Product
- OSTOSTEORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID COBRAID Suture, Blue; Part Number: 72201994 Biodegradable suture anchor
- Where it went
- Worldwide Distribution - USA (nationwide) Canada, Europe: Austria, Belgium, Cyprus, Czech Republic, Denmark, Germany, Greece, Finland, France, Italy, Ireland, Luxembourg, Netherlands, Norway, Poland, Portugal, Russia, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine and United Kingdom, Asia-pacific: Australia, China, Dubai, Hong Kong, India, Japan, Malaysia, New Zealand, Philippines, Sri Lanka, Singapore, South Korea, Taiwan, Thailand, Argentina, Bermuda, Brazil, Chile, Colombia, Costa Rica, Israel, Mexico, Puerto Rico, South Africa, and Venezuela.
- How much
- 6373 US
TWINFIX ULTRA PLLA/HA 5.5 mm Suture Anchor with 3 ULTRABRAID Suture: Part Number: 72202603 Biodegradable su
Z-2234-2013 · Class II · reported 2013-09-25 · Terminated
- Why it was recalled
- Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
- Product
- TWINFIX ULTRA PLLA/HA 5.5 mm Suture Anchor with 3 ULTRABRAID Suture: Part Number: 72202603 Biodegradable suture anchor
- Where it went
- Worldwide Distribution - USA (nationwide) Canada, Europe: Austria, Belgium, Cyprus, Czech Republic, Denmark, Germany, Greece, Finland, France, Italy, Ireland, Luxembourg, Netherlands, Norway, Poland, Portugal, Russia, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine and United Kingdom, Asia-pacific: Australia, China, Dubai, Hong Kong, India, Japan, Malaysia, New Zealand, Philippines, Sri Lanka, Singapore, South Korea, Taiwan, Thailand, Argentina, Bermuda, Brazil, Chile, Colombia, Costa Rica, Israel, Mexico, Puerto Rico, South Africa, and Venezuela.
- How much
- N/A
TWINFIX Ultra HA 5.5 mm Suture Anchor with 2 ULTRABRAID Suture, Blue / Black; Part Number: 72202626 Biodeg
Z-2231-2013 · Class II · reported 2013-09-25 · Terminated
- Why it was recalled
- Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
- Product
- TWINFIX Ultra HA 5.5 mm Suture Anchor with 2 ULTRABRAID Suture, Blue / Black; Part Number: 72202626 Biodegradable suture anchor
- Where it went
- Worldwide Distribution - USA (nationwide) Canada, Europe: Austria, Belgium, Cyprus, Czech Republic, Denmark, Germany, Greece, Finland, France, Italy, Ireland, Luxembourg, Netherlands, Norway, Poland, Portugal, Russia, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine and United Kingdom, Asia-pacific: Australia, China, Dubai, Hong Kong, India, Japan, Malaysia, New Zealand, Philippines, Sri Lanka, Singapore, South Korea, Taiwan, Thailand, Argentina, Bermuda, Brazil, Chile, Colombia, Costa Rica, Israel, Mexico, Puerto Rico, South Africa, and Venezuela.
- How much
- 3827 US
TWINFIX Ultra PLLA/HA 5.5 mm Suture Anchor with 2 ULTRABRAID Suture, White / Black: Part Number: 72202602 B
Z-2233-2013 · Class II · reported 2013-09-25 · Terminated
- Why it was recalled
- Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
- Product
- TWINFIX Ultra PLLA/HA 5.5 mm Suture Anchor with 2 ULTRABRAID Suture, White / Black: Part Number: 72202602 Biodegradable suture anchor
- Where it went
- Worldwide Distribution - USA (nationwide) Canada, Europe: Austria, Belgium, Cyprus, Czech Republic, Denmark, Germany, Greece, Finland, France, Italy, Ireland, Luxembourg, Netherlands, Norway, Poland, Portugal, Russia, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine and United Kingdom, Asia-pacific: Australia, China, Dubai, Hong Kong, India, Japan, Malaysia, New Zealand, Philippines, Sri Lanka, Singapore, South Korea, Taiwan, Thailand, Argentina, Bermuda, Brazil, Chile, Colombia, Costa Rica, Israel, Mexico, Puerto Rico, South Africa, and Venezuela.
- How much
- 7148 US
BIORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID Suture; Part Number: 72200774 Biodegradable suture anchor
Z-2216-2013 · Class II · reported 2013-09-25 · Terminated
- Why it was recalled
- Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
- Product
- BIORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID Suture; Part Number: 72200774 Biodegradable suture anchor
- Where it went
- Worldwide Distribution - USA (nationwide) Canada, Europe: Austria, Belgium, Cyprus, Czech Republic, Denmark, Germany, Greece, Finland, France, Italy, Ireland, Luxembourg, Netherlands, Norway, Poland, Portugal, Russia, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine and United Kingdom, Asia-pacific: Australia, China, Dubai, Hong Kong, India, Japan, Malaysia, New Zealand, Philippines, Sri Lanka, Singapore, South Korea, Taiwan, Thailand, Argentina, Bermuda, Brazil, Chile, Colombia, Costa Rica, Israel, Mexico, Puerto Rico, South Africa, and Venezuela.
- How much
- 24574 US
BIORAPTOR 2.9 mm Suture Anchor, pack of 1 ULTRABRAID Suture: 72200689 Biodegradable suture anchor
Z-2219-2013 · Class II · reported 2013-09-25 · Terminated
- Why it was recalled
- Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
- Product
- BIORAPTOR 2.9 mm Suture Anchor, pack of 1 ULTRABRAID Suture: 72200689 Biodegradable suture anchor
- Where it went
- Worldwide Distribution - USA (nationwide) Canada, Europe: Austria, Belgium, Cyprus, Czech Republic, Denmark, Germany, Greece, Finland, France, Italy, Ireland, Luxembourg, Netherlands, Norway, Poland, Portugal, Russia, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine and United Kingdom, Asia-pacific: Australia, China, Dubai, Hong Kong, India, Japan, Malaysia, New Zealand, Philippines, Sri Lanka, Singapore, South Korea, Taiwan, Thailand, Argentina, Bermuda, Brazil, Chile, Colombia, Costa Rica, Israel, Mexico, Puerto Rico, South Africa, and Venezuela.
- How much
- 240 US
TWINFIX Ultra PLLA/HA 6.5 mm with 3 ULTRABRAID Suture; Part Number: 72202610 Biodegradable suture anchor
Z-2236-2013 · Class II · reported 2013-09-25 · Terminated
- Why it was recalled
- Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
- Product
- TWINFIX Ultra PLLA/HA 6.5 mm with 3 ULTRABRAID Suture; Part Number: 72202610 Biodegradable suture anchor
- Where it went
- Worldwide Distribution - USA (nationwide) Canada, Europe: Austria, Belgium, Cyprus, Czech Republic, Denmark, Germany, Greece, Finland, France, Italy, Ireland, Luxembourg, Netherlands, Norway, Poland, Portugal, Russia, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine and United Kingdom, Asia-pacific: Australia, China, Dubai, Hong Kong, India, Japan, Malaysia, New Zealand, Philippines, Sri Lanka, Singapore, South Korea, Taiwan, Thailand, Argentina, Bermuda, Brazil, Chile, Colombia, Costa Rica, Israel, Mexico, Puerto Rico, South Africa, and Venezuela.
- How much
- 1643
TWINFIX Ultra HA 6.5 mm with 2 ULTRABRAID Suture, Blue / Black; Part Number: 72202631 Biodegradable suture
Z-2232-2013 · Class II · reported 2013-09-25 · Terminated
- Why it was recalled
- Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
- Product
- TWINFIX Ultra HA 6.5 mm with 2 ULTRABRAID Suture, Blue / Black; Part Number: 72202631 Biodegradable suture anchor
- Where it went
- Worldwide Distribution - USA (nationwide) Canada, Europe: Austria, Belgium, Cyprus, Czech Republic, Denmark, Germany, Greece, Finland, France, Italy, Ireland, Luxembourg, Netherlands, Norway, Poland, Portugal, Russia, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine and United Kingdom, Asia-pacific: Australia, China, Dubai, Hong Kong, India, Japan, Malaysia, New Zealand, Philippines, Sri Lanka, Singapore, South Korea, Taiwan, Thailand, Argentina, Bermuda, Brazil, Chile, Colombia, Costa Rica, Israel, Mexico, Puerto Rico, South Africa, and Venezuela.
- How much
- 708 US
BIORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture; Part Number: 72200775 Biodegradable suture anchor
Z-2215-2013 · Class II · reported 2013-09-25 · Terminated
- Why it was recalled
- Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
- Product
- BIORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture; Part Number: 72200775 Biodegradable suture anchor
- Where it went
- Worldwide Distribution - USA (nationwide) Canada, Europe: Austria, Belgium, Cyprus, Czech Republic, Denmark, Germany, Greece, Finland, France, Italy, Ireland, Luxembourg, Netherlands, Norway, Poland, Portugal, Russia, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine and United Kingdom, Asia-pacific: Australia, China, Dubai, Hong Kong, India, Japan, Malaysia, New Zealand, Philippines, Sri Lanka, Singapore, South Korea, Taiwan, Thailand, Argentina, Bermuda, Brazil, Chile, Colombia, Costa Rica, Israel, Mexico, Puerto Rico, South Africa, and Venezuela.
- How much
- 43385 US
RAPTORMITE" 3.7 mm PLLA with two ULTRABRAID" Sutures Size 0 and Needles; Part Number: 72201805 Biodegradabl
Z-2237-2013 · Class II · reported 2013-09-25 · Terminated
- Why it was recalled
- Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
- Product
- RAPTORMITE" 3.7 mm PLLA with two ULTRABRAID" Sutures Size 0 and Needles; Part Number: 72201805 Biodegradable suture anchor
- Where it went
- Worldwide Distribution - USA (nationwide) Canada, Europe: Austria, Belgium, Cyprus, Czech Republic, Denmark, Germany, Greece, Finland, France, Italy, Ireland, Luxembourg, Netherlands, Norway, Poland, Portugal, Russia, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine and United Kingdom, Asia-pacific: Australia, China, Dubai, Hong Kong, India, Japan, Malaysia, New Zealand, Philippines, Sri Lanka, Singapore, South Korea, Taiwan, Thailand, Argentina, Bermuda, Brazil, Chile, Colombia, Costa Rica, Israel, Mexico, Puerto Rico, South Africa, and Venezuela.
- How much
- 1965 US
BIORAPTOR 2.9 mm Suture Anchor with DURABRAID" Suture; Part Number: 72200783 Biodegradable suture anchor
Z-2217-2013 · Class II · reported 2013-09-25 · Terminated
- Why it was recalled
- Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
- Product
- BIORAPTOR 2.9 mm Suture Anchor with DURABRAID" Suture; Part Number: 72200783 Biodegradable suture anchor
- Where it went
- Worldwide Distribution - USA (nationwide) Canada, Europe: Austria, Belgium, Cyprus, Czech Republic, Denmark, Germany, Greece, Finland, France, Italy, Ireland, Luxembourg, Netherlands, Norway, Poland, Portugal, Russia, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine and United Kingdom, Asia-pacific: Australia, China, Dubai, Hong Kong, India, Japan, Malaysia, New Zealand, Philippines, Sri Lanka, Singapore, South Korea, Taiwan, Thailand, Argentina, Bermuda, Brazil, Chile, Colombia, Costa Rica, Israel, Mexico, Puerto Rico, South Africa, and Venezuela.
- How much
- 1735 US
TWINFIX Ultra HA 4.5 mm Suture Anchor with 2 ULTRABRAID Suture, White / Blue; Part Number: 72202597 Biodeg
Z-2229-2013 · Class II · reported 2013-09-25 · Terminated
- Why it was recalled
- Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
- Product
- TWINFIX Ultra HA 4.5 mm Suture Anchor with 2 ULTRABRAID Suture, White / Blue; Part Number: 72202597 Biodegradable suture anchor
- Where it went
- Worldwide Distribution - USA (nationwide) Canada, Europe: Austria, Belgium, Cyprus, Czech Republic, Denmark, Germany, Greece, Finland, France, Italy, Ireland, Luxembourg, Netherlands, Norway, Poland, Portugal, Russia, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine and United Kingdom, Asia-pacific: Australia, China, Dubai, Hong Kong, India, Japan, Malaysia, New Zealand, Philippines, Sri Lanka, Singapore, South Korea, Taiwan, Thailand, Argentina, Bermuda, Brazil, Chile, Colombia, Costa Rica, Israel, Mexico, Puerto Rico, South Africa, and Venezuela.
- How much
- 8889 US
OSTEORAPTOR 2.3 mm with 1 ULTRABRAID Suture, White; Part Number: 72201991 Biodegradable suture anchor
Z-2222-2013 · Class II · reported 2013-09-25 · Terminated
- Why it was recalled
- Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
- Product
- OSTEORAPTOR 2.3 mm with 1 ULTRABRAID Suture, White; Part Number: 72201991 Biodegradable suture anchor
- Where it went
- Worldwide Distribution - USA (nationwide) Canada, Europe: Austria, Belgium, Cyprus, Czech Republic, Denmark, Germany, Greece, Finland, France, Italy, Ireland, Luxembourg, Netherlands, Norway, Poland, Portugal, Russia, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine and United Kingdom, Asia-pacific: Australia, China, Dubai, Hong Kong, India, Japan, Malaysia, New Zealand, Philippines, Sri Lanka, Singapore, South Korea, Taiwan, Thailand, Argentina, Bermuda, Brazil, Chile, Colombia, Costa Rica, Israel, Mexico, Puerto Rico, South Africa, and Venezuela.
- How much
- 22879 US
OSTEORAPTOR CURVED 2.3 mm Suture Anchor ULTRABRAID COBRAID Suture, Black; Part Number: 72203291 Biodegrada
Z-2227-2013 · Class II · reported 2013-09-25 · Terminated
- Why it was recalled
- Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
- Product
- OSTEORAPTOR CURVED 2.3 mm Suture Anchor ULTRABRAID COBRAID Suture, Black; Part Number: 72203291 Biodegradable suture anchor
- Where it went
- Worldwide Distribution - USA (nationwide) Canada, Europe: Austria, Belgium, Cyprus, Czech Republic, Denmark, Germany, Greece, Finland, France, Italy, Ireland, Luxembourg, Netherlands, Norway, Poland, Portugal, Russia, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine and United Kingdom, Asia-pacific: Australia, China, Dubai, Hong Kong, India, Japan, Malaysia, New Zealand, Philippines, Sri Lanka, Singapore, South Korea, Taiwan, Thailand, Argentina, Bermuda, Brazil, Chile, Colombia, Costa Rica, Israel, Mexico, Puerto Rico, South Africa, and Venezuela.
- How much
- 4946 US
TWINFIX Ultra 6.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (blue, blue-COBRAID) with Needles; P
Z-2240-2013 · Class II · reported 2013-09-25 · Terminated
- Why it was recalled
- Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
- Product
- TWINFIX Ultra 6.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (blue, blue-COBRAID) with Needles; Part Number: 72202620 Biodegradable suture anchor
- Where it went
- Worldwide Distribution - USA (nationwide) Canada, Europe: Austria, Belgium, Cyprus, Czech Republic, Denmark, Germany, Greece, Finland, France, Italy, Ireland, Luxembourg, Netherlands, Norway, Poland, Portugal, Russia, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine and United Kingdom, Asia-pacific: Australia, China, Dubai, Hong Kong, India, Japan, Malaysia, New Zealand, Philippines, Sri Lanka, Singapore, South Korea, Taiwan, Thailand, Argentina, Bermuda, Brazil, Chile, Colombia, Costa Rica, Israel, Mexico, Puerto Rico, South Africa, and Venezuela.
- How much
- 314 US
TWINFIX" Ultra 4.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (blue, blue-COBRAID") with Needles;
Z-2238-2013 · Class II · reported 2013-09-25 · Terminated
- Why it was recalled
- Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
- Product
- TWINFIX" Ultra 4.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (blue, blue-COBRAID") with Needles; Part Number: 72202612 Biodegradable suture anchor
- Where it went
- Worldwide Distribution - USA (nationwide) Canada, Europe: Austria, Belgium, Cyprus, Czech Republic, Denmark, Germany, Greece, Finland, France, Italy, Ireland, Luxembourg, Netherlands, Norway, Poland, Portugal, Russia, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine and United Kingdom, Asia-pacific: Australia, China, Dubai, Hong Kong, India, Japan, Malaysia, New Zealand, Philippines, Sri Lanka, Singapore, South Korea, Taiwan, Thailand, Argentina, Bermuda, Brazil, Chile, Colombia, Costa Rica, Israel, Mexico, Puerto Rico, South Africa, and Venezuela.
- How much
- 1571 US
OSTEORAPTOR 2.3 mm Suture Anchor with ULTRABRAID COBRAID Suture, Blue; Part Number: 72201993 Biodegradabl
Z-2220-2013 · Class II · reported 2013-09-25 · Terminated
- Why it was recalled
- Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
- Product
- OSTEORAPTOR 2.3 mm Suture Anchor with ULTRABRAID COBRAID Suture, Blue; Part Number: 72201993 Biodegradable suture anchor
- Where it went
- Worldwide Distribution - USA (nationwide) Canada, Europe: Austria, Belgium, Cyprus, Czech Republic, Denmark, Germany, Greece, Finland, France, Italy, Ireland, Luxembourg, Netherlands, Norway, Poland, Portugal, Russia, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine and United Kingdom, Asia-pacific: Australia, China, Dubai, Hong Kong, India, Japan, Malaysia, New Zealand, Philippines, Sri Lanka, Singapore, South Korea, Taiwan, Thailand, Argentina, Bermuda, Brazil, Chile, Colombia, Costa Rica, Israel, Mexico, Puerto Rico, South Africa, and Venezuela.
- How much
- 25733
Showing the 30 most recent of 37. 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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