FDA Medical Device Recalls (openFDA)
Zimmer Inc.: Spinal Concepts snap-fix polyaxial screwdriver, Manufactured by Spinal Concepts, Austin, TX, REF 781-3.
- Recall number
- Z-0605-2011
- Recalling firm
- Zimmer Inc.
- Product
- Spinal Concepts snap-fix polyaxial screwdriver, Manufactured by Spinal Concepts, Austin, TX, REF 781-3.
- Status
- Terminated
- Initiated
- 2005-12-01
- Posted
- 2010-12-10
- Terminated
- 2011-06-01
- Reason
- The devices may fracture, resulting in surgical delay or the need for intervention to remove fragments from the surgical site.
- Root cause
- Device Design
- Action
- The affected instruments were removed and replaced in the U.S. Abbott Spine and Spinal Concepts instrument kits between December 2005 and October 2007. User accounts were not advised of the removal Zimmer has confirmed that none of these instruments are currently available for use in the U.S. For further information about this action, contact Dale Miller of Zimmer at 574 372-4962.
- Quantity
- 26
- Distribution
- Worldwide Distribution, including US.
- Lot, serial or model codes
- Lots 32TX and 32TY.
- 510(k) numbers
- ["K031985","K052247","K052566","K060634"]
- PMA numbers
- not on file
- Product code
- KWQ
- Firm FEI
- 1000220733
- Firm city
- Warsaw
- Firm state
- IN
- 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