Reported Oct 2, 2013 · Terminated
Universal Titanium Prosthesis, Round Head, with Flex H/A titanium shoe. The ear prosthesis is implantable and indicated…
Medtronic Xomed, 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: Medtronic Xomed, Inc. · 6743 Southpoint Dr N · Jacksonville, FL · 32216-6218
Is this the product you have?
- Universal Titanium Prosthesis, Round Head, with Flex H/A titanium shoe. The ear prosthesis is implantable and indicated for hearing loss.
- Lot codes and dates
- REF1150000
- Lot0207029284
- Amount recalled
- 60
Where it was sold
Why it was recalled
One lot of the product was assembled using the Cam Head version of the same prosthesis instead of the Round head Shaft.
This product could cause temporary or reversible health problems — stop using it.
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