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U.S. Department of Health and Human Services

Class 2 Device Recall Accolade TMZF Plus Femoral Stem

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 Class 2 Recall
Accolade TMZF Plus Femoral Stem
see related information
Date Posted January 08, 2013
Recall Status1 Terminated on September 11, 2013
Recall Number Z-0656-2013
Recall Event ID 61718
Premarket Notification
510(K) Number
K994366 
Product Classification Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate - Product Code MEH
Product Accolade TMZF Plus 127 degree Neck Angle V40 Hip Stem #2.5 and Accolade TMZF Plus 127 degree Neck Angle V40 Hip Stem #3.5, Howmedica Osteonics Corp. The intended use is for reconstruction of the head and neck of the femoral joint.
Code Information Catalog Number: 6021-2530 Lot #40264005 Catalog Number: 6021-3535 Lot #40163005. This lot was not received in the US.
Recalling Firm/
Manufacturer
Stryker Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah, New Jersey 07430
For Additional Information Contact Ms. Colleen O'Meara
201-972-2100
Manufacturer Reason
for Recall
Stryker has received a report that single size 3.5 stem was packaged as size 2.5 stem resulting in a possible product mix.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Labeling Mix-Ups
Action Stryker sent "Urgent Medical Device Recall Notification" letters and product accountability forms via Fed Ex with return receipt on 10/23/12 to branches/agencies and to hospitals and physicians on 10/24/12. The letter described the issue and provided recommended actions to mitigate the risk. Customers can call (201) 972-2100 if questions.
Quantity in Commerce 6021-2530- four units; 6021-3535-
Distribution Nationwide distribution, including the states of NY, NJ, CA and FL.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MEH and Original Applicant = HOWMEDICA OSTEONICS CORP.
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