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U.S. Department of Health and Human Services

Class 2 Device Recall Modular Cathcart Fracture Head Hip Ball

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 Class 2 Device Recall Modular Cathcart Fracture Head Hip Ballsee related information
Date Initiated by FirmMay 18, 2022
Create DateJuly 12, 2022
Recall Status1 Open3, Classified
Recall NumberZ-1375-2022
Recall Event ID 90476
510(K)NumberK903084 
Product Classification Prosthesis, hip, hemi-, femoral, metal ball - Product Code LZY
ProductMODULAR 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
Code Information All lots until Instructions for Use (IFU) is revised
Recalling Firm/
Manufacturer		 DePuy Orthopaedics, Inc.
700 Orthopaedic Dr
Warsaw IN 46582-3994
For Additional Information ContactKimberly Long
574-267-8156
Manufacturer 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.
FDA Determined
Cause 2		Labeling design
ActionOn 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 Commerce3488
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = LZY
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