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U.S. Department of Health and Human Services

Class 2 Device Recall TOM(R) Bone Mill

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 Class 2 Recall
TOM(R) Bone Mill
see related information
Date Posted March 23, 2010
Recall Status1 Terminated on November 24, 2010
Recall Number Z-1202-2010
Recall Event ID 54663
Product Classification Orthopedic Manual Surgical Instrument - Product Code LXH
Product Tessier Osseous Microtome TOM(R) Bone Mill, 01-15402, Stryker Portage, MI. The TOM bone mill is designed to grind any type of cortical or cancellous bone.
Code Information all lots.
Recalling Firm/
Manufacturer
Stryker Craniomaxillofacial Division
750 Trade Centre Way Ste 200
Portage, Michigan 49002-0482
For Additional Information Contact Rob Yamishita
877-534-2464
Manufacturer Reason
for Recall
The firm has received 328 customer complaints for this device. Most of the complaints were involving non-functioning of the ratcheting handle or complete device, or the presence of metal shavings or discoloration.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Equipment Maintenance
Action An "URGENT MEDICAL DEVICE CORRECTION" letter dated February 18, 2010, was sent to the customers. The letter describes the product, problem, scope of affected products, potential patient risks and actions to be taken by the customers. The customers should review the letter with all users of the TOM(r) Bone Mill and follow the instructions on the proper inspection and maintenance of the device enclosed with the letter. The customers should fax the accountability form within 5 days to help Stryker ensure their receipt of the information. If the accountability form is not received, addition communication will be sent. If you have any urgent questions or concerns, please contact us at (269) 323-4258. Please ref: PFA #2009-128. Our normal business hours are Monday-Friday 8am-5pm (GMT+1:00) On 7/8/2010 the firm sent an Urgent Medical Device Recall letter to its customers. The letter stated thatt upon consultation with regulatory agencies outside of the United States, the firm had intiated a devicd removal. The letter instructed the customers to return any devices that they had to the recalling firm.
Quantity in Commerce 596 units
Distribution Worldwide distribution: USA and Belarus, Bulgaria, Denmark, Finland, Hungary, Jordan, Norway, Russia, Saudi Arabia and the UAE.
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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