FDA Medical Device Recalls (openFDA)
Stryker Instruments, Instruments Div.: Stryker Advanced Cement Mixing System Bowl and 180 Gram Cement Cartridge with Break-Away Femoral Nozzle for use with Stryker high vacuum cement injection system, 6 pack; part 0306-563-000.
- Recall number
- Z-0921-03
- Recalling firm
- Stryker Instruments, Instruments Div.
- Product
- Stryker Advanced Cement Mixing System Bowl and 180 Gram Cement Cartridge with Break-Away Femoral Nozzle for use with Stryker high vacuum cement injection system, 6 pack; part 0306-563-000.
- Status
- Terminated
- Initiated
- 2003-06-01
- Posted
- 2003-07-29
- Terminated
- 2003-11-13
- Reason
- Non-sterilized product sold as sterile.
- Root cause
- Other
- Action
- Sales representatives were notified on June 1, 2003 and requested to contact their accounts to determine if any product remained on the shelf. Recall letters dated June 12, 2003 were sent to each customer''s risk manager, surgical director and hospital administrator via certified mail
- Quantity
- 440 boxes
- Distribution
- United States, Canada, Italy, Japan and United Kingdom
- Lot, serial or model codes
- lot 03030232.
- 510(k) numbers
- ["K912190"]
- PMA numbers
- not on file
- Product code
- not on file
- Firm FEI
- 1811755
- Firm city
- Kalamazoo
- Firm state
- MI
- 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