Reported Jul 20, 2022 · Ongoing
MODULAR CATHCART FRACTURE HEAD HIP BALL, sizes 41mm to 60mm inclusive; metallic femoral head prosthesis, Product No.…
DePuy Orthopaedics, 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: DePuy Orthopaedics, Inc. · 700 Orthopaedic Dr · Warsaw, IN · 46582-3994
Is this the product you have?
MODULAR CATHCART FRACTURE HEAD HIP BALLsizes 41mm to 60mm inclusivemetallic femoral head prosthesisProduct No. 136341000136342000136343000136344000136345000136346000136347000136348000136349000136350000136351000136352000136353000136354000136356000136358000136360000
- Lot codes and dates
- All lots until Instructions for Use (IFU) is revised
- Amount recalled
- 3488
Where it was sold
- Nationwide
Why it was recalled
The Cathcart Ball has an inherent +5mm offset which is not currently specified in its Instructions for Use or Surgical Technique Guide. The STG has been updated to reflect the clarification that the +5mm offset should be taken into consideration when using a Cathcart head in a construct for hemi-hip arthroplasty procedures.
This product could cause temporary or reversible health problems — stop using it.
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