Reported Oct 30, 2019 · Terminated
OMNI Hip System Model, Catalogue, or Order Number(s): HC-00070 Intended for use as the femoral component of a primary…
OMNIlife science 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: OMNIlife science Inc. · 480 Paramount Dr · Raynham, MA · 02767-1085
Is this the product you have?
- OMNI Hip System Model, Catalogue
- or Order Number(s)HC-00070 Intended for use as the femoral component of a primary or revision total hip replacement
- Lot codes and dates
- Lot # 33035
- Amount recalled
- 3 units
Where it was sold
Why it was recalled
Stems missing porous coating on the device.
This product could cause temporary or reversible health problems — stop using it.
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