Reported Sep 18, 2024 · Ongoing
ROTATION MEDICAL TENDON STAPLES (8) (narrow indication)-Intended for fixation of prosthetic material to soft tissues.…
Smith & Nephew Inc.
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. · 150 Minuteman Rd · Andover, MA · 01810-1031
Is this the product you have?
- ROTATION MEDICAL TENDON STAPLES (8) (narrow indication)-Intended for fixation of prosthetic material to soft tissues
- Product Number72205201
- Lot codes and dates
- UDI-DI00885556733486
- Batch Numbers
5119213651192143511921445119214551192146511921485119215051192151511921525119215351192154512044805120448151204484512044855120448651204487512044885120448951204491512231935122324151223242512232435122324951224282
- Amount recalled
- 2961 units (OUS)
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Product packaging process may result in an improper or incomplete seal of the outer foil pouch surrounding the inner Tyvek pouch, compromising product sterility
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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