Reported Oct 12, 2016 · Terminated
Arthrex Suture Washer
Arthrex, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.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: Arthrex, Inc. · 1370 Creekside Blvd · Naples, FL · 34108-1945
Is this the product you have?
- Arthrex Suture Washer
- Lot codes and dates
- Unique Device Identifier (UDI)
00888867118607Catalog # AR-7000-18TBatch #10028617
- Unique Device Identifier (UDI)
- Amount recalled
- 45 devices
Where it was sold
Why it was recalled
The device was assembled incorrectly. Suture and washer were not assembled; components were placed loose in the package.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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