CLASS II Device recall · Reported 25 Sep 2013 · FDA Enforcement Report
Twinfix" Ultra Plla-ha Suture Anchor recalled by Smith & Nephew, Inc.
Smith & Nephew Inc. Endoscopy Division is recalling Twinfix" Ultra Plla-ha Suture Anchor with two #2 Ultrabraid Sutures (blue, blue-Cobraid"), distributed nationwide in the US. The recall was initiated on 6 Aug 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2238-2013
- FDA event ID
- 66037
- Recalling firm
- Smith & Nephew Inc. Endoscopy Division, Andover, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Aug 2013
- FDA classified
- 17 Sep 2013
- Reported
- 25 Sep 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Surgical Instruments
Timeline
| 6 Aug 2013 | Recall initiated by company | |
| 17 Sep 2013 | Classified by FDA | +42 days |
| 25 Sep 2013 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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 was distributed
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.
Questions about this recall
Why was it recalled?
Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
Which lots are affected?
50373723 50389654 50389655 50397577 50397596 50397599 50397605 50417226 50431744 50431853 50433695 50437528 50440608 50441690 50447116 50447118 50447119 50448227 50454009 50454867 50461412 50467503 50469159 50470653
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
25 other products · FDA event 66037This product is part of a recall event; the main page for the event is Osteoraptor Suture Anchor with 1 Ultrabraid Cobraid Suture, Black recalled.
More recalls from Smith & Nephew Inc. Endoscopy Division
All 37| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Suturefix Ultra Anchor XL recalled by Smith & Nephew, Inc. | Smith & Nephew Inc. Endoscopy Division | Sterility | Nationwide |
| Device | CLASS II | Suturefix Ultra Anchor XL with one (#2) Ultrabraid Blue Product recalled | Smith & Nephew Inc. Endoscopy Division | Sterility | Nationwide |
| Device | CLASS II | Suturefix Ultra S Double Loaded Suture Product recalled | Smith & Nephew Inc. Endoscopy Division | Sterility | Nationwide |
| Device | CLASS II | Suturefix Ultra S with 1 #2 Ultrabraid Suture (blue/white) Product recalled | Smith & Nephew Inc. Endoscopy Division | Sterility | Nationwide |
| Device | CLASS II | Suturefix Ultra S with 1 #2 Ultrabraid (blue) Product recalled | Smith & Nephew Inc. Endoscopy Division | Sterility | Nationwide |
Other Surgical Instruments recalls
All 3,809| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits: IV Start KIT recalled by Medline Industries | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Packaging Defects | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled | ConMed | Other | Nationwide |