Reported Jul 30, 2014 · Terminated
NOVATION Femoral Stem, Tapered Extended offset, plasma- coated, press fit. Catalog number 160-01-13 intended to be…
Exactech, 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: Exactech, Inc. · 2320 NW 66th Ct · Gainesville, FL · 32653-1630
Is this the product you have?
- NOVATION Femoral Stem, Tapered Extended offset, plasma- coated, press fit. Catalog number 160-01-13 intended to be implanted to replace a hip joint with our without bone cement.
- Lot codes and dates
- Serial Numbers
291024329102442910245291024629102472910248291024929102502910251and 2910252
- Serial Numbers
- Amount recalled
- 10
Why it was recalled
The femoral stem is lacking specified plasma coating.
This product could cause temporary or reversible health problems — stop using it.
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