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U.S. Department of Health and Human Services

Class 2 Device Recall SecurFit Max Hip Stem

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  Class 2 Device Recall SecurFit Max Hip Stem see related information
Date Initiated by Firm November 13, 2008
Date Posted January 26, 2009
Recall Status1 Terminated 3 on January 20, 2010
Recall Number Z-0893-2009
Recall Event ID 50485
510(K)Number K041170  
Product Classification prosthesis, hip, - Product Code LZO
Product Secur-Fit Max Hip Stem

These devices are modular components of a total hip system. These femoral stems are intended for use with femoral heads and acetabular components in primary or revision total hip arthroplasty.
Code Information 6051-0625S SECUR-FIT MAX 132 HIP STEM #6 HKNMME, 6051-0730S SECUR-FIT MAX 132 HIP STEM #7 K03MME, 6051-0730S SECUR-FIT MAX 132 HIP STEM #7 K08MME, 6051-0830S SECUR-FIT MAX 132 HIP STEM #8 E56MLE, 6051-0830S SECUR-FIT MAX 132 HIP STEM #8 J41MLE, 6051-0935S SECUR-FIT MAX 132 HIP STEM #9 EN1MME, 6051-1035S SECUR-FIT MAX 132 HIP STEM #10 70PMME, 6051-1140S SECUR-FIT MAX 132 HIP STEM #11 4PMMME, 6051-1140S SECUR-FIT MAX 132 HIP STEM #11 901MME, 6052-0830S SECUR-FIT MAX 127 HIP STEM #8 V3PMLE, 6052-0935S SECUR-FIT MAX 127 HIP STEM #9 5ERMME, 6052-1035S SECUR-FIT MAX 127 HIP STEM #10 69WMME, 6052-1035S SECUR-FIT MAX 127 HIP STEM #10 AL8MME and 6052-1240S SECUR-FIT MAX 127 HIP STEM #12 EP4MME 
Recalling Firm/
Manufacturer		 Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430
For Additional Information Contact Karen Ariemma, RAC
201-831-5000
Manufacturer Reason
for Recall		 Stryker Orthopaedics became aware of a visual defect in certain blister packages of certain devices.
FDA Determined
Cause 2		 Packaging
Action Recall notification letters were sent via Federal Express on November 21, 2008 to Stryker Branches/Agencies, Hospital Risk Management, Chief of Orthopaedics and Surgeon. The letters explained the problem and indicated that there are no risk factors. Contact Stryker Orthopaedics for additional information at 1-201-831-5718.
Quantity in Commerce 322 total units - all types
Distribution Nationwide. OUS: Australia, Canada, Japan, Argentina, Brazil, Germany, Spain, Columbia, Guatemala and Sweden.
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 = LZO and Original Applicant = HOWMEDICA OSTEONICS CORP.
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