FDA Medical Device Recalls (openFDA)
Zimmer Inc.: Zimmer / Abbott Spine Sequoia dorsal height & revision tool, non-sterile; REF 3367-1. Surgical instrument for pedicle screw system.
- Recall number
- Z-0554-2010
- Recalling firm
- Zimmer Inc.
- Product
- Zimmer / Abbott Spine Sequoia dorsal height & revision tool, non-sterile; REF 3367-1. Surgical instrument for pedicle screw system.
- Status
- Terminated
- Initiated
- 2009-08-20
- Posted
- 2009-12-22
- Terminated
- 2011-04-13
- Reason
- The tip of the instrument may fracture during use.
- Root cause
- Device Design
- Action
- Zimmer sent a letter dated 8/17/09 to distributors and consignees on or about 8/20/09. Users were notified of the potential problem via the letter and advised that the instruments will be removed and replaced when a new version of the instrument becomes available (around 10/09).
- Quantity
- 215
- Distribution
- Nationwide, Belgium and New Zealand.
- Lot, serial or model codes
- Lots 47PN, 47PP, 49HK, 49HL and 57WL.
- 510(k) numbers
- ["K082032"]
- PMA numbers
- not on file
- Product code
- NKB
- 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