Recall Z-1106-2008 ยท JDZ Mixer, Cement, For Clinical Use
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.
| Date | May 1, 2008 (initiated Jan 10, 2008) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.