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Open, Classified

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

FDA Recall Z-1375-2022 · Posted None

Recalling FirmDePuy Orthopaedics, Inc.
Recall StatusOpen, Classified
Product CodeLZY
Date Initiated2022-05-18
Product Quantity3488

Reason for Recall

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.

Firm 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.

Root Cause

Labeling design

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K903084MODULAR CATHCART FRACTURE SYSTEMDepuy, Inc. · 1990-10-03

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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