Reported Sep 25, 2013 · Terminated
TWINFIX Ultra HA 4.5 mm Suture Anchor with 2 ULTRABRAID Suture, Blue / Black; Part Number: 72202624 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 4.5 mm Suture Anchor with 2 ULTRABRAID Suture, Blue / Black
- Part Number72202624 Biodegradable suture anchor
- Lot codes and dates
67 of 67 codes
503247085032514950326625503367175033710650339395503398435034197750344395503480675034969150350416503520285035329450354590503566305035874150360275503622935036352950368587503714555037477850376047503792055038279850385696503878715038802450390982503924045039580050400928504036995040537850408699504107835041586350417200504189885042926850429637504296385042983050430372504312215043892450439176504397825044081950442646504428745044666250447248504488295044944250449829504504605045121450452940
- Amount recalled
- 6985 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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