Date Initiated by Firm | August 14, 2008 |
Date Posted | October 28, 2008 |
Recall Status1 |
Terminated 3 on May 29, 2012 |
Recall Number | Z-0191-2009 |
Recall Event ID |
49497 |
Product Classification |
Reduction Spoon - Product Code LXH
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Product | Stryker Osteosynthesis Reduction Spoon;
1 single unit to a package; non-sterile;
Stryker Trauma GmbH, 2432 Schonkirchen, Germany.
Distributed in the US by Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 007430
Reduction spoons are sold separately or as part of a kit. The Universal Rod with Reduction Spoon may be used as a fracture reduction tool to facilitate Guide Wire insertion. |
Code Information |
Product Code 1806-0125 All product made before design change in 2003. Refer to picture provided showing differences in device. |
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 has become aware of the potential for breakage of the Reduction Spoon designed prior to 2003. |
FDA Determined Cause 2 | Device Design |
Action | Recall notification letters were sent on August 14, 2008 to all branches and hospitals via Federal Express. Questions are to be directed to 201-831-5718 or a Trauma team member listed in the letter. |
Quantity in Commerce | 1070 units |
Distribution | Nationwide |
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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