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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker Osteosynthesis

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  Class 2 Device Recall Stryker Osteosynthesis see related information
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
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/
Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430
For Additional Information Contact Karen Ariemma, RAC
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

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.