Stryker Advanced Cement Mixer (ACM) Bowl and Base without 180 Gram Cement Cartridge for use with Stryker High Vacuum Cem
FDA device recall Z-1106-2008 · posted 2008-05-01 · Terminated
Recall details
- Recalling firm
- Stryker Instruments Div. of Stryker Corporation
- Reason for recall
- Sterility may be compromised, as the packaging may have channels in the packaging seal.
- Action taken
- Stryker notified consignees via Medical Device Recall Notification letter dated 1/10/08 to quarantine the product and to return it.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- JDZ
- Quantity affected
- 25 boxes of 6 each
- Distribution
- Nationwide Distribution - Illinois, Michigan, New York, Ohio and Wyoming.
- Date initiated
- 2008-01-10
- Date posted
- 2008-05-01
- Date terminated
- 2008-07-31
- Location
- Portage, MI
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