Z-1375-2022Class II

MODULAR CATHCART FRACTURE HEAD HIP BALL, sizes 41mm to 60mm inclusive; metallic femoral head prosthesis...

Name: Z-1375-2022 MODULAR CATHCART FRACTURE HEAD HIP BALL, sizes 41mm to 60mm inclusive; metallic femoral head prosthesis...
Creator: DePuy Orthopaedics, Inc.
Published: 2022-05-18
License: https://open.fda.gov/license/

Depuy Orthopaedics Inc. / initiated 2022-05-18 / Open, Classified / root cause: labeling and UDI

FDA source

DePuy Orthopaedics, Inc. began a recall of MODULAR CATHCART FRACTURE HEAD HIP BALL, sizes 41mm to 60mm inclusive; metallic femoral head prosthesis, Product No. 136341000, 136342000, 136343000... on 2022-05-18. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1375-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-05-18
Posted: 2022-07-12
Recalling firm: Depuy Orthopaedics Inc.
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
Product code: LZY Prosthesis, Hip, Hemi-, Femoral, Metal Ball
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.
Root cause tag: labeling and UDI
FDA 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 in commerce: 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.
Product codes and lots: All lots until Instructions for Use (IFU) is revised

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1375-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1375-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-07-20	2022-07-12

Product code LZY

K903084Class IIModular Cathcart Fracture SystemDepuy, Inc. / cleared 1990-10-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)