Tessier Osseous Microtome TOM(R) Bone Mill, 01-15402, Stryker Portage, MI. The TOM bone mill is designed to grind any ty

FDA device recall Z-1202-2010 · posted 2010-03-23 · Terminated

Recall details

Recalling firm

Stryker Craniomaxillofacial Division

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.

Action taken

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.

Root cause

Equipment maintenance

Status

Terminated

Product code

LXH

Quantity affected

596 units

Distribution

Worldwide distribution: USA and Belarus, Bulgaria, Denmark, Finland, Hungary, Jordan, Norway, Russia, Saudi Arabia and the UAE.

Date initiated

2010-02-18

Date posted

2010-03-23

Date terminated

2010-11-24

Location

Portage, MI