The FDA announced on May 18, 2022, that DePuy Orthopaedics, Inc. is recalling MODULAR CATHCART FRACTURE HEAD HIP BALLs due to an unspecified +5mm offset in its documentation. The agency issued recall number Z-1375-2022 for the Class II device.
How to tell if you have it
- Brand: DePuy
- Product: MODULAR CATHCART FRACTURE HEAD HIP BALL, metallic femoral head prosthesis
- Sizes: 41mm to 60mm inclusive
- Product Nos.: 136341000, 136342000, 136343000, 136344000, 136345000, 136346000, 136347000, 136348000, 136349000, 136350000, 136351000, 136352000, 136353000, 136354000, 136356000, 136358000, 136360000
- Lots: All lots until Instructions for Use is revised
- Distribution: US Nationwide and Australia, Austria, Belgium, Canada, Denmark, Finland, Germany, Greece, Guam, Hong Kong, Ireland, Netherlands, New Zealand, Norway, South Africa, Spain, Sweden, Switzerland, United Kingdom
The 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.
Context
GovInfoNow's records show DePuy Orthopaedics, Inc. has 23 other recalls on record since 2017-07-12. Other recent recalls of similar products include DePuy Orthopaedics Recalls ATTUNE Knee Component Due to Incorrect Labeling (2024-03-12), DePuy Attune Revision Limb Preservation Tibial Insert XSM 26MM Recall: Radiation Dose Risk (2023-02-15), and DePuy ATTUNE Sizing Guide Recall: Corroded Spring Risks Surgical Complications (2022-06-29).