Reported Nov 28, 2012 · Terminated
Ranawat/Burnstein Acetabular Shell 54mm/Limited Holes/Porous Coated is a metallic, full-hemisphere, acetabular shell…
Biomet, 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: Biomet, Inc. · 56 E Bell Dr · Warsaw, IN · 46582-6989
Is this the product you have?
- Ranawat/Burnstein Acetabular Shell 54mm/Limited Holes/Porous Coated is a metallic, full-hemisphere, acetabular shell component
- Intended UseThe shell utilizes a modular polyethylene liner and a femoral head component that is taper fit onto a femoral stem at the time of surgery. Cemented or non-cemented total hip replacement . The device is intended for general use in skeletally mature individuals undergoing primary and/or secondary revision surgery at high risk of hip dislocation due to a history of prior dislocation, joint or bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered
- Lot codes and dates
- Part 11-106054 Lot 528310
- Amount recalled
- 16 (5 USA)
Where it was sold
Why it was recalled
The color code on label conflicts with the liner size (liner size 24 should be green, not yellow)
This product could cause temporary or reversible health problems — stop using it.
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