Reported Sep 25, 2013 · Terminated
TWINFIX Ultra PLLA/HA 6.5 mm with 3 ULTRABRAID Suture; Part Number: 72202610 Biodegradable suture anchor
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 PLLA/HA 6.5 mm with 3 ULTRABRAID Suture
- Part Number72202610 Biodegradable suture anchor
- Lot codes and dates
503251665032516750327043503367375033677250339647503398425034197650385698503974655041229050417528504264525042781850429624504298745043156350453525
- Amount recalled
- 1643
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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