Reported Dec 11, 2024 · Ongoing
BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor.
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?
- BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor.
- Lot codes and dates
Part No. 72201541722015427220328072203281
- UDI-DI
03596010595072035960105950890359601065645203596010656469Batch No. 214636921512422151690215469121534892151692
- Amount recalled
- 2,156 units
Where it was sold
Why it was recalled
Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the device.
This product could cause temporary or reversible health problems — stop using it.
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