Reported Aug 15, 2012 · Terminated
Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with three #2 sutures (white, COBRAID- blue), sterile Part Number:…
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?
- Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with three #2 sutures (white, COBRAID- blue)
- sterile Part Number72202897
- Product Usageintended for use for the reattachment of soft tissue to bone
- Lot codes and dates
- Lot Numbers
50388188503892685039243150393764503948995039567550396849503974645039872750399817504001845040208250403278504050855040619750406805504089945041000150412043504129675041426050415224504165425041568150417216504184915042066050421624
- Lot Numbers
- Amount recalled
- 4,411 units
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Distal part of the anchor may break on insertion into bone during surgery
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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