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-2230-2013
- 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 4.5 mm Suture Anchor with 2 ULTRABRAID Suture, Blue / Black; Part Number: 72202624 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?
50324708 50325149 50326625 50336717 50337106 50339395 50339843 50341977 50344395 50348067 50349691 50350416 50352028 50353294 50354590 50356630 50358741 50360275 50362293 50363529 50368587 50371455 50374778 50376047 50379205 50382798 50385696 50387871 50388024 50390982 50392404 50395800 50400928 50403699 50405378 50408699 50410783 50415863 50417200 50418988 50429268 50429637 50429638 50429830 50430372 50431221 50438924 50439176 50439782 50440819 50442646 50442874 50446662 50447248 50448829 50449442 50449829 50450460 50451214 50452940 50453996 50456042 50456043 50456044 50456595 50458432 50458472
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 |