Reported Sep 14, 2016 · Terminated
Hard Tissue Replacement (HTR) Implant, Rx only, for use in single procedure only. Custom made. HTR polymer implants are…
Biomet Microfixation, LLC
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: Biomet Microfixation, LLC · 1520 Tradeport Dr · Jacksonville, FL · 32218-2480
Is this the product you have?
- Hard Tissue Replacement (HTR) Implant, Rx only, for use in single procedure only. Custom made. HTR polymer implants are intended for bone replacement/augmentation for treatment of craniofacial voids/defects resulting from disease, injury, or surgical trauma.
- Lot codes and dates
- Custom made, one per customer. Affected units were sealed between April 28, 2016 and June 7, 2016
- Amount recalled
- 54 units
Where it was sold
Why it was recalled
Potential sterility deficiency.
This product could cause temporary or reversible health problems — stop using it.
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