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U.S. Department of Health and Human Services

Class 2 Device Recall Accolade II 127 Neck Angle Hip Stem

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 Class 2 Recall
Accolade II 127 Neck Angle Hip Stem
see related information
Date Posted December 07, 2013
Recall Status1 Terminated on March 31, 2015
Recall Number Z-0467-2014
Recall Event ID 66761
Premarket Notification
510(K) Number
Product Classification Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented - Product Code JDI
Product 1) Accolade II 127 Neck Angle Hip Stem, Size # 3 2) Accolade II 127 Neck Angle Hip Stem, Size #5 Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 USA Telephone # +1 201-831-5000 Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881 MEYZIEU Cedex France Intended for cementless application in total or hemiarthroplasty procedures.
Code Information 510K K120578 Accolade II I27 Neck Angle Hip Stem, Size # 3 Catalog No.# 6721-0330 Lot Code #44416307 Accolade II 127 Neck Angle Hip Stem, Size #5 Catalog No. # 6721-0535 Lot Code 44564405
Recalling Firm/
Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah, New Jersey 07430-2002
For Additional Information Contact Ms. Christie Samsa
Manufacturer Reason
for Recall
Stryker received a report from the field indicating that an Accolade II Hip Stem Size #3 was identified in packaging with an Accolade II Hip Stem Size #5.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Packaging Process Control
Action Stryker sent an e-mail to their domestic locations on 10/11/2013. Notification letters and product accountability forms were sent via Fed Ex on 10/25/2013 with return receipt to branches/agencies and hospital risk management, chief of orthopaedics and surgeons.
Quantity in Commerce 20 units
Distribution Nationwide Distribution including states: AL, GA, IL, and WA.
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 = JDI and Original Applicant = HOWMEDICA OSTEONICS