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DePuy Orthopaedics, Inc. recalls MODULAR CATHCART FRACTURE HEAD HIP BALL, sizes 41mm to 60mm inclusive; metallic femoral head prosthesis, Product No. 136
Recalled July 20, 2022 · FDA recall Z-1375-2022 · DePuy Orthopaedics
Hazard
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. · FDA Class II
Units
3488
Sold at
Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Denmark, Finland, Germany, Greece, Guam, Hong Kong, Ireland, Netherlands, New Zealand, Norway, South Africa, Spain, Sweden, Switzerland, United Kingdom.
Description
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.
Product
MODULAR CATHCART FRACTURE HEAD HIP BALL, sizes 41mm to 60mm inclusive; metallic femoral head prosthesis, Product No. 136341000, 136342000, 136343000, 136344000, 136345000, 136346000, 136347000, 136348000, 136349000, 136350000, 136351000, 136352000, 136353000, 136354000, 136356000, 136358000, 136360000
Manufacturer(s)
DePuy Orthopaedics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →