ATO Drill Guide Kit (All Through One Drill Guides Set), model number 07.00860.001, product is packaged in trays.
This recall has been terminated (originally issued October 23, 2004).
- Company
- Zimmer Spine, Inc.
- Recall Initiated
- August 24, 2004
- Posted
- October 23, 2004
- Terminated
- November 3, 2005
- Recall Number
- Z-0040-05
- Quantity
- 82 sets
- Firm Location
- Minneapolis, MN
- Official Source
- View on FDA website ↗
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.
Distribution
Product was distributed nationwide throughout the United States. Product was not distributed outside of the United States.
Lot / Code Info
Serial Numbers: ATO-001 through ATO-0082
Root Cause
Other
Action Taken
The product distributed to accounts will be returned to Zimmer Spine. Product will be quarantined pending investigation and determination of appropriate corrective action.