FDA Medical Device Recalls (openFDA)
Stryker Craniomaxillofacial Division: 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.
- Recall number
- Z-1202-2010
- Recalling firm
- Stryker Craniomaxillofacial Division
- 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.
- Status
- Terminated
- Initiated
- 2010-02-18
- Posted
- 2010-03-23
- Terminated
- 2010-11-24
- Reason
- 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.
- Root cause
- 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
- 596 units
- Distribution
- Worldwide distribution: USA and Belarus, Bulgaria, Denmark, Finland, Hungary, Jordan, Norway, Russia, Saudi Arabia and the UAE.
- Lot, serial or model codes
- all lots.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LXH
- Firm FEI
- 3005101424
- Firm city
- Portage
- Firm state
- MI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28