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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker Osteosynthesis

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 Class 2 Recall
Stryker Osteosynthesis
see related information
Date Posted October 28, 2008
Recall Status1 Open
Recall Number Z-0191-2009
Recall Event ID 49497
Product Classification Orthopedic Manual Surgical Instrument - 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/
Manufacturer
Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah, New Jersey 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
DESIGN: Process 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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