Recall Z-1375-2022 ยท LZY Prosthesis, Hip, Hemi-, Femoral, Metal Ball
DePuy Orthopaedics, Inc.
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
| Date | May 18, 2022 |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Labeling design |
| Action | On June 13, 2022, the firm notified distributed recall letters to customers titled URGENT FIELD SAFETY NOTICE. Customers were instructed to contact their local sales consultant to receive a copy of the revised STG (reference document number DSUS/JRC/0317/2044 Rev B). Product is not being removed from the field. |
| Quantity | 3488 |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K903084 | MODULAR CATHCART FRACTURE SYSTEM Depuy, Inc., Oct 3, 1990 |