FDA Medical Device Recalls (openFDA)
Zimmer Inc.: Abbott Spine Thoracolumbar Common, SpdLnk 5.5 Trans Cntr Med 43-51 mm, non-sterile, Manufactured by Abbott Spine, Inc., Austin, TX; Ref. 1302-55M. Note: This lot was not distributed in the United States. The component is used in the stabilization of constructs in the BacFix and InCompass spinal fixation systems. It is used within a temporary construct that assists normal healing and is not intended to replace normal body structures.
- Recall number
- Z-0525-2010
- Recalling firm
- Zimmer Inc.
- Product
- Abbott Spine Thoracolumbar Common, SpdLnk 5.5 Trans Cntr Med 43-51 mm, non-sterile, Manufactured by Abbott Spine, Inc., Austin, TX; Ref. 1302-55M. Note: This lot was not distributed in the United States. The component is used in the stabilization of constructs in the BacFix and InCompass spinal fixation systems. It is used within a temporary construct that assists normal healing and is not intended to replace normal body structures.
- Status
- Terminated
- Initiated
- 2009-09-21
- Posted
- 2009-12-14
- Terminated
- 2010-10-08
- Reason
- The titanium stock used to manufacturer the product is reported to exhibit areas of alloy segregation, which could result in a weakening of the strength of the metal.
- Root cause
- Nonconforming Material/Component
- Action
- Consignees were notified by letter dated September 21, 2009 and instructed to return the affected product to Zimmer, Inc.
- Quantity
- 13
- Distribution
- Worldwide Distribution -- Canada, Mexico and South Africa. (Product not distributed in the United States)
- Lot, serial or model codes
- Lot 55QJ.
- 510(k) numbers
- ["K002082"]
- PMA numbers
- not on file
- Product code
- KWP
- 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