FDA Medical Device Recalls (openFDA)
Warsaw Orthopedic, Inc.: Medtronic Sofamor Danek brand LT CAGE lumbar tapered fusion device implant 14 mm x 17.5 mm x 23 mm; Catalog number 8941423.
- Recall number
- Z-1090-05
- Recalling firm
- Warsaw Orthopedic, Inc.
- Product
- Medtronic Sofamor Danek brand LT CAGE lumbar tapered fusion device implant 14 mm x 17.5 mm x 23 mm; Catalog number 8941423.
- Status
- Terminated
- Initiated
- 2005-05-27
- Posted
- 2005-08-06
- Terminated
- 2005-09-20
- Reason
- The product is labeled as sterile, but this lot was not sterilized.
- Root cause
- Other
- Action
- not on file
- Quantity
- 140
- Distribution
- United States and Canada.
- Lot, serial or model codes
- Lot W05C5509.
- 510(k) numbers
- not on file
- PMA numbers
- ["P970015"]
- Product code
- MAX
- Firm FEI
- 1824199
- 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