FDA Medical Device Recalls (openFDA)
Zimmer Inc.: Zimmer Dynesys top-loading cutter, spacer, Zimmer Spine, Minneapolis, MN; REF 07.01284.001.
- Recall number
- Z-0370-2010
- Recalling firm
- Zimmer Inc.
- Product
- Zimmer Dynesys top-loading cutter, spacer, Zimmer Spine, Minneapolis, MN; REF 07.01284.001.
- Status
- Terminated
- Initiated
- 2009-05-28
- Posted
- 2009-11-19
- Terminated
- 2011-10-05
- Reason
- The spacer cutter may jam during surgery, preventing use of the instrument and causing surgical delay.
- Root cause
- Other
- Action
- Consignees were notified by letter dated 5/20/09 titled "Urgent Medical Device Correction" that instructed customers that they may continue to use the recalled product until adequate replacements become available, but that they should always ensure they have a backup spacer cutter (of a different model which does not have this issue) available in case this model should jam during use. Users were also advised to ensure the spacer cutter is properly lubricated and is sharp. For questions, please contact Zimmer Spine at 1-800-777-7505.
- Quantity
- 177
- Distribution
- Nationwide, Austria, Belgium, Canada, Italy, Netherlands, Singapore, Spain, Switzerland and United Kingdom.
- Lot, serial or model codes
- All lots. Lots 60859166, 60859167, 61085708. 60970745, 61024375, 61024376 and 61123514.
- 510(k) numbers
- ["K073347"]
- PMA numbers
- not on file
- Product code
- NQP
- 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