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U.S. Department of Health and Human Services

Class 2 Device Recall Universal Femoral Sleeve Full Porous

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  Class 2 Device Recall Universal Femoral Sleeve Full Porous see related information
Date Initiated by Firm January 08, 2021
Create Date February 09, 2021
Recall Status1 Open3, Classified
Recall Number Z-1103-2021
Recall Event ID 87189
510(K)Number K063633  
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Product Universal Femoral Sleeves - Product Usage: used primarily in revision surgeries with the S-ROM Noiles, LPS, SIGMA, and LCS Knee products.
Code Information Product No.: 129453216, 129453226, 129453236,129453246 Lot No.: J85Y90, J86T23, J86T20, J8790J, J85Y92 
Recalling Firm/
Manufacturer
DePuy Orthopaedics, Inc.
700 Orthopaedic Dr
Warsaw IN 46582-3994
For Additional Information Contact Shannon Rook
610-314-2088
Manufacturer Reason
for Recall
The taper dimensions may be out of specification due to a production issue during the manufacturing of these lots.
FDA Determined
Cause 2
Nonconforming Material/Component
Action On 01/12/2021, DePuy Synthes issued an Urgent Medical Device Recall (removal) via letter due to taper dimensions of certain Universal Femoral Sleeves may be out of specification. The Universal Femoral Sleeves are used primarily in revision surgeries with the S-ROM Noiles, LPS, SIGMA, and LCS Knee products. DePuy is recommending that customers return the recalled devices.
Quantity in Commerce 60 sleeves
Distribution Worldwide distribution - US Nationwide distribution in the states of AK, CA, FL, IN, MI, MN, MS, NC, NY, OH, PA, TX, VA and the countries of Canada, China, Germany, Puerto Rico, Switzerland.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = JWH and Original Applicant = DEPUY ORTHOPAEDICS, INC.
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