Recall Z-0040-05 ยท KWQ Appliance, Fixation, Spinal Intervertebral Body
Zimmer Spine, Inc.
ATO Drill Guide Kit (All Through One Drill Guides Set), model number 07.00860.001, product is packaged in trays.
| Date | Oct 23, 2004 (initiated Aug 24, 2004) |
| Status | Terminated |
| Reason | 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. |
| 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 | 82 sets |
| Distribution | Product was distributed nationwide throughout the United States. Product was not distributed outside of the United States. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.