CLASS II Device recall · Reported 25 Sep 2013 · FDA Enforcement Report
Twinfix Ultra HA Suture Anchor with 2 Ultrabraid Suture recalled
Smith & Nephew Inc. Endoscopy Division is recalling Twinfix Ultra HA Suture Anchor with 2 Ultrabraid Suture, Blue / Black, 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-2231-2013
- 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 HA 5.5 mm Suture Anchor with 2 ULTRABRAID Suture, Blue / Black; Part Number: 72202626 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?
50324715 50324960 50326833 50336719 50336768 50339643 50339651 50341854 50344396 50348650 50349838 50350841 50351449 50353295 50360151 50363875 50368586 50372045 50374017 50375716 50378770 50381624 50387868 50390937 50395330 50397700 50402973 50404638 50406692 50408058 50412954 50415137 50416799 50418989 50429269 50429640 50429642 50429832 50431134 50439753 50439754 50442740 50443625
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 |