Z-0040-05

ATO Drill Guide Kit (All Through One Drill Guides Set), model number 07.00860.001, product is packaged in...

Name: Z-0040-05 ATO Drill Guide Kit (All Through One Drill Guides Set), model number 07.00860.001, product is packaged in...
Creator: Zimmer Spine, Inc.
Published: 2004-08-24
License: https://open.fda.gov/license/

Zimmer Spine, Inc. / initiated 2004-08-24 / Terminated

FDA source

Zimmer Spine, Inc. began a recall of ATO Drill Guide Kit (All Through One Drill Guides Set), model number 07.00860.001, product is packaged in trays on 2004-08-24. The reason FDA records is "To date, there has been one complaint reported. During a Trinica surgical case, the surgeon was provided a standard disposable, Trinica Drill Bit (part number 07.00166.001) for use with the Trinica All Through One Drill...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0040-05
Status: Terminated
Initiated: 2004-08-24
Posted: 2004-10-23
Terminated: 2005-11-03
Recalling firm: Zimmer Spine, Inc.
Product: ATO Drill Guide Kit (All Through One Drill Guides Set), model number 07.00860.001, product is packaged in trays.
Product code: KWQ Appliance, Fixation, Spinal Intervertebral Body
Reason for recall: To date, there has been one complaint reported. During a Trinica surgical case, the surgeon was provided a standard disposable, Trinica Drill Bit (part number 07.00166.001) for use with the Trinica All Through One Drill Guide Instrumentation, instead of the ALL Through One Drill Bit. This enabled the physician to drill a few millimeters further than expected.
FDA root cause: Other
Action: The product distributed to accounts will be returned to Zimmer Spine. Product will be quarantined pending investigation and determination of appropriate corrective action.
Quantity in commerce: 82 sets
Distribution: Product was distributed nationwide throughout the United States. Product was not distributed outside of the United States.
Product codes and lots: Serial Numbers: ATO-001 through ATO-0082

Product code KWQ

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)