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Class 2 Device Recall Modular Cathcart Fracture Head Hip Ball |
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Date Initiated by Firm |
May 18, 2022 |
Create Date |
July 12, 2022 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-1375-2022 |
Recall Event ID |
90476 |
510(K)Number |
K903084
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Product Classification |
Prosthesis, hip, hemi-, femoral, metal ball - Product Code LZY
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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 |
Code Information |
All lots until Instructions for Use (IFU) is revised |
Recalling Firm/ Manufacturer |
DePuy Orthopaedics, Inc. 700 Orthopaedic Dr Warsaw IN 46582-3994
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For Additional Information Contact |
Kimberly Long 574-267-8156
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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.
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FDA Determined Cause 2 |
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. |
Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = LZY and Original Applicant = DEPUY, INC.
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