Z-1202-2010

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

Name: Z-1202-2010 Tessier Osseous Microtome TOM(R) Bone Mill, 01-15402, Stryker Portage, MI. The TOM bone mill is designed to...
Creator: Stryker Craniomaxillofacial Division
Published: 2010-02-18
License: https://open.fda.gov/license/

Stryker Craniomaxillofacial Division / initiated 2010-02-18 / Terminated / root cause: manufacturing process

FDA source

Stryker Craniomaxillofacial Division began a recall of 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 on 2010-02-18. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1202-2010
Status: Terminated
Initiated: 2010-02-18
Posted: 2010-03-23
Terminated: 2010-11-24
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.
Product code: LXH Orthopedic Manual Surgical Instrument
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 596 units
Distribution: Worldwide distribution: USA and Belarus, Bulgaria, Denmark, Finland, Hungary, Jordan, Norway, Russia, Saudi Arabia and the UAE.
Product codes and lots: all lots.

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)