Recall Z-1194-2008 ยท JDZ Mixer, Cement, For Clinical Use
Stryker Instruments Div. of Stryker Corporation
Stryker VertePort, 10 G Access Canula (short), REF 306-430, Qty 6; For use with the Stryker PCD Precision System and ACM Delivery System, Rx only, sterile, Stryker Instruments, Kalamazoo, MI.
| Date | Mar 11, 2008 (initiated Feb 13, 2008) |
| Status | Terminated |
| Reason | Mis-labeling; The instructions for use include a use for which the device is not intended. (Device not approved to capture a bone biopsy) |
| Root cause | Labeling Change Control |
| Action | Consignees were notified via Medical Device Recall Notification letter dated 2/13/08 to read the enclosed instructions for use, remove all old instructions for use at the consignee location and replace them with the new instructions for use, and to discard the old instructions for use. |
| Quantity | 953 boxes Recalls Z-1192-1195-2008 |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.