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Terminated

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

FDA Recall Z-0040-05 · Posted 2004-10-23

Recalling FirmZimmer Spine, Inc.
Recall StatusTerminated
Product CodeKWQ
Date Initiated2004-08-24
Date Terminated2005-11-03
Product Quantity82 sets

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.

Firm Action

The product distributed to accounts will be returned to Zimmer Spine. Product will be quarantined pending investigation and determination of appropriate corrective action.

Root Cause

Other

Distribution Pattern

Product was distributed nationwide throughout the United States. Product was not distributed outside of the United States.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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