FDA Medical Device Recalls (openFDA)
Zimmer Spine, Inc.: Trinica Bone Tap Instrument, Catalog Number 07.00168.001, sold separately and as part of Zimmer Spine Trinica Anterior Cervical Plating Instrument sets (catalog numbers 07.00215.001 and 07.00546.001). Only the Trinica Bone Tap Instruments are being recalled from the sets.
- Recall number
- Z-1014-04
- Recalling firm
- Zimmer Spine, Inc.
- Product
- Trinica Bone Tap Instrument, Catalog Number 07.00168.001, sold separately and as part of Zimmer Spine Trinica Anterior Cervical Plating Instrument sets (catalog numbers 07.00215.001 and 07.00546.001). Only the Trinica Bone Tap Instruments are being recalled from the sets.
- Status
- Terminated
- Initiated
- 2004-05-21
- Posted
- 2005-02-24
- Terminated
- 2005-11-03
- Reason
- The recalled bone taps could break inside the vertebral body during the tapping process.
- Root cause
- Other
- Action
- Recall letters, dated May 25, 2004, request that the consignees locate and return the recalled devices.
- Quantity
- 55 units
- Distribution
- The product was shipped to Hawaii, New York, South Carolina, and South Dakota in the United States.
- Lot, serial or model codes
- Lot P020077.
- 510(k) numbers
- ["K022344"]
- PMA numbers
- not on file
- Product code
- HWX
- 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