Reported Jun 22, 2016 · Terminated
BioSync Anatomic Cotton Wedge, 16 x 5.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies…
Arthrex, 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: Arthrex, Inc. · 1370 Creekside Blvd · Naples, FL · 34108-1945
Is this the product you have?
- BioSync Anatomic Cotton Wedge, 16 x 5.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.
- Lot codes and dates
Catalog #: AR-8948W-1655Batch #: 10019147
- Unique Device Identifier00888867202726
- Amount recalled
- 138 total products
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
Why it was recalled
Potential for polystyrene particulate presence.
This product could cause temporary or reversible health problems — stop using it.
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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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