Z-1246-2009

Zimmer TM-400 Broach Handle; Part No. 96-210-10001. The product is a surgical instrument for use in...

Name: Z-1246-2009 Zimmer TM-400 Broach Handle; Part No. 96-210-10001. The product is a surgical instrument for use in...
Creator: Zimmer Inc.
Published: 2009-04-29
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2009-04-29 / Terminated / root cause: design

FDA source

Zimmer Inc. began a recall of Zimmer TM-400 Broach Handle; Part No. 96-210-10001. The product is a surgical instrument for use in conjunction with Zimmer TM-400 Trabecular Metal implants... on 2009-04-29. The reason FDA records is "The broach handle may fracture at the threaded tip during use, which would result in surgical intervention to retrieve the broach or the trial as the threaded tip fragment prevents attachment of another handle to...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1246-2009
Status: Terminated
Initiated: 2009-04-29
Posted: 2009-07-07
Terminated: 2010-10-08
Recalling firm: Zimmer GmbH
Product: Zimmer TM-400 Broach Handle; Part No. 96-210-10001. The product is a surgical instrument for use in conjunction with Zimmer TM-400 Trabecular Metal implants during spinal surgery. The Broach Handle threads onto various broaches and trial implants. The handle with these broaches or trials attached is used to prepare and measure a vertebral space to accept a TM-400 Trabecular Metal implant.
Product code: HTQ Broach
Reason for recall: The broach handle may fracture at the threaded tip during use, which would result in surgical intervention to retrieve the broach or the trial as the threaded tip fragment prevents attachment of another handle to retrieve the device.
Root cause tag: design
FDA root cause: Device Design
Action: Distributors and user accounts were notified by "Urgent: Medical Device Recall" letter dated April 29, 2009. The letter described the affected product, reason for recall, health risks, and action for consignees. Distributors were instructed to retrieve the devices and to return them to Zimmer no later than May 13, 2009. This instrument recall will result in an inability to implant the associated devices until a new instrument becomes available. For questions or assistance about the recall please contact Zimmer Spine by calling 800-777-7505.
Quantity in commerce: 435
Distribution: Nationwide, Austria, Australia, Belgium, Canada, Finland, Germany, Greece, Korea, South Africa, Sweden, Switzerland, Taiwan and the United Kingdom.
Product codes and lots: All lots.

Product code HTQ

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)