FDA Medical Device Recalls (openFDA)
Zimmer Spine, Inc.: ATO Drill Guide Kit (All Through One Drill Guides Set), model number 07.00860.001, product is packaged in trays.
- Recall number
- Z-0040-05
- 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.
- Status
- Terminated
- Initiated
- 2004-08-24
- Posted
- 2004-10-23
- Terminated
- 2005-11-03
- 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.
- Lot, serial or model codes
- Serial Numbers: ATO-001 through ATO-0082
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KWQ
- Firm FEI
- 1000115775
- Firm city
- Minneapolis
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28