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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker TOM

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 Class 2 Recall
Stryker TOM
see related information
Date Posted February 27, 2007
Recall Status1 Terminated on June 04, 2008
Recall Number Z-0521-2007
Recall Event ID 37067
Product Classification Orthopedic Manual Surgical Instrument - Product Code LXH
Product Stryker Tom Tessier Osseous Microtome: Plug for Bone Mill Systems (Parts 01-15400 and 01-15401), Stryker Leiblinger Inc., Kalamazoo, MI; Part 01-15407.
Code Information Lots G4C00F72HN, G5H00F72HN, G7T00F72HN, G8W00F72HN and G9700F72HN.
Recalling Firm/
Manufacturer
Stryker Leibinger USA
750 Trade Center Way Ste 200
Portage, Michigan 49002-0482
Manufacturer Reason
for Recall
Metal shavings come off of the plug as a result of friction between the plug and the cutting cylinder, and may be mixed with the milled bone chips.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action Consignees were notified via recall letter dated 12/22/06 which instructed them to quarantine the product and to contact the firm for further instructions.
Quantity in Commerce 26
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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