Date Initiated by Firm | October 04, 2005 |
Date Posted | November 18, 2005 |
Recall Status1 |
Terminated 3 on May 04, 2006 |
Recall Number | Z-0166-06 |
Recall Event ID |
33895 |
510(K)Number | K021026 |
Product Classification |
Screw, Fixation, Bone - Product Code HWC
|
Product | S2 System, Locking Screw Partially Threaded |
Code Information |
Catalog No. 1791-5065S to 1791-5120S |
Recalling Firm/ Manufacturer |
Stryker Howmedica Osteonics Corp. 325 Corporate Dr Mahwah NJ 07430-2002
|
For Additional Information Contact | Dominick Cristofolo 201-831 Ext. 5247 |
Manufacturer Reason for Recall | Stryker Orthopaedics was informed by the manufacturer, that in some instances, the sterile blister package of the referenced G/K, T2 condyle and some S2 screw products may become damaged during shipping and handling which may result in a potential breach of the sterile barrier.
|
FDA Determined Cause 2 | Other |
Action | The product recall will extend to all branches.agencies and hospitals that have received the product. |
Quantity in Commerce | 171 units |
Distribution | nationwide |
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 = HWC
|