Reported Sep 25, 2013 · Terminated
TWINFIX Ultra HA 5.5 mm Suture Anchor with 2 ULTRABRAID Suture, Blue / Black; Part Number: 72202626 Biodegradable…
Smith & Nephew, Inc. Endoscopy Division
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Smith & Nephew, Inc. Endoscopy Division · 150 Minuteman Drive · Andover, MA · 01810-1031
Is this the product you have?
- TWINFIX Ultra HA 5.5 mm Suture Anchor with 2 ULTRABRAID Suture, Blue / Black
- Part Number72202626 Biodegradable suture anchor
- Lot codes and dates
50324715503249605032683350336719503367685033964350339651503418545034439650348650503498385035084150351449503532955036015150363875503685865037204550374017503757165037877050381624503878685039093750395330503977005040297350404638504066925040805850412954504151375041679950418989504292695042964050429642504298325043113450439753504397545044274050443625
- Amount recalled
- 3827 US
This recall covers 26 products
The agency filed one notice per product. You are reading one of them; the other 25 are below.
13 more are in the archive.
Where it was sold
- Nationwide
- PR
Why it was recalled
Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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