Reported Sep 2, 2015 · Terminated
Offset Femoral Alignment Guide, 2mm x 6¿; Product Code: KS 67022 Product Usage: The instrumentation has been designed…
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. · 50 Oconnell Way Ste 10 · East Taunton, MA · 02718-1394
Is this the product you have?
- Offset Femoral Alignment Guide, 2mm x 6¿
- Product CodeKS 67022
- Product UsageThe instrumentation has been designed to facilitate bone preparation and implantation of the Apex Knee or Apex Hip Systems
- Lot codes and dates
- Lot Numbers
MM0314RVA0713Z1111
- Lot Numbers
- Amount recalled
- 15
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
The markings on both versions of the OFFSET FEMORAL ALIGNMENT GUIDES are incorrect. Specifically, the markings on the alignment guides are reversed from the intended position that should provide proper alignment for the offset revision stems when used with the femur.
This product could cause temporary or reversible health problems — stop using it.
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