Z-0521-2007

Stryker Tom Tessier Osseous Microtome: Plug for Bone Mill Systems (Parts 01-15400 and 01-15401), Stryker...

Name: Z-0521-2007 Stryker Tom Tessier Osseous Microtome: Plug for Bone Mill Systems (Parts 01-15400 and 01-15401), Stryker...
Creator: Stryker Leibinger USA
Published: 2006-12-22
License: https://open.fda.gov/license/

Stryker Craniomaxillofacial Division / initiated 2006-12-22 / Terminated

FDA source

Stryker Leibinger USA began a recall of Stryker Tom Tessier Osseous Microtome: Plug for Bone Mill Systems (Parts 01-15400 and 01-15401), Stryker Leiblinger Inc., Kalamazoo, MI; Part 01-15407 on 2006-12-22. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0521-2007
Status: Terminated
Initiated: 2006-12-22
Posted: 2007-02-27
Terminated: 2008-06-04
Recalling firm: Stryker Craniomaxillofacial Division
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.
Product code: LXH Orthopedic Manual Surgical Instrument
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 root cause: Other
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.
Product codes and lots: Lots G4C00F72HN, G5H00F72HN, G7T00F72HN, G8W00F72HN and G9700F72HN.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)