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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 Device Recall Accolade II 127 Neck Angle Hip Stem see related information
Date Initiated by Firm October 25, 2013
Date Posting Updated December 07, 2013
Recall Status1 Terminated 3 on March 31, 2015
Recall Number Z-0467-2014
Recall Event ID 66761
510(K)Number K120578  
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/
Manufacturer
Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430-2002
For Additional Information Contact Ms. Christie Samsa
201-831-6365
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
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 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) Database 510(K)s with Product Code = JDI and Original Applicant = HOWMEDICA OSTEONICS
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