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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 Poroussee related information
Date Initiated by FirmJanuary 08, 2021
Create DateFebruary 09, 2021
Recall Status1 Terminated 3 on January 17, 2024
Recall NumberZ-1103-2021
Recall Event ID 87189
510(K)NumberK063633 
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
ProductUniversal 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 ContactShannon 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
ActionOn 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 Commerce60 sleeves
DistributionWorldwide 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 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = JWH
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