Date Initiated by Firm | November 13, 2008 |
Date Posted | January 26, 2009 |
Recall Status1 |
Terminated 3 on January 20, 2010 |
Recall Number | Z-0898-2009 |
Recall Event ID |
50485 |
510(K)Number | K983226 |
Product Classification |
prosthesis, hip, - Product Code JDI
|
Product | Omnifit FC Cemented 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 |
6093-1035 OMNIFIT-FC CEMENTED STEM 28RMLE and 6093-1035 ONMIFIT FC CEMENTED STEM 3DHME |
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 |
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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.
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510(K) Database | 510(K)s with Product Code = JDI
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