Reported May 21, 2014 · Terminated
PS-C Femoral Nonporous Rt Sz 6, Model Number 161-1604 Component of the Balanced Knee System and Balanced Knee Revision…
Ortho Development Corporation
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: Ortho Development Corporation · 12187 Business Park Dr · Draper, UT · 84020-8663
Is this the product you have?
- PS-C Femoral Nonporous Rt Sz 6, Model Number 161-1604 Component of the Balanced Knee System and Balanced Knee Revision System, for total knee arthroplasty procedures.
- Lot codes and dates
- Lot No. A131876
- Amount recalled
- 5
Where it was sold
Why it was recalled
A femoral component containing pegs was found in a box for the pegless version.
This product could cause temporary or reversible health problems — stop using it.
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