FDA Medical Device Recalls (openFDA)
Stryker Instruments Div. of Stryker Corporation: Stryker Advanced Cement Mixer (ACM) Bowl and Base without 180 Gram Cement Cartridge for use with Stryker High Vacuum Cement Injection System, sterile; REF 306-554, Stryker Instruments, Kalamazoo, MI 49001.
- Recall number
- Z-1106-2008
- Recalling firm
- Stryker Instruments Div. of Stryker Corporation
- Product
- Stryker Advanced Cement Mixer (ACM) Bowl and Base without 180 Gram Cement Cartridge for use with Stryker High Vacuum Cement Injection System, sterile; REF 306-554, Stryker Instruments, Kalamazoo, MI 49001.
- Status
- Terminated
- Initiated
- 2008-01-10
- Posted
- 2008-05-01
- Terminated
- 2008-07-31
- Reason
- Sterility may be compromised, as the packaging may have channels in the packaging seal.
- Root cause
- Nonconforming Material/Component
- Action
- Stryker notified consignees via Medical Device Recall Notification letter dated 1/10/08 to quarantine the product and to return it.
- Quantity
- 25 boxes of 6 each
- Distribution
- Nationwide Distribution - Illinois, Michigan, New York, Ohio and Wyoming.
- Lot, serial or model codes
- Lot Numbers: 05167CG2, 05192012, 05223012 and 06335012.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JDZ
- Firm FEI
- 1811755
- Firm city
- Portage
- 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