Stryker VertePort, 10 G Cement Cannula, REF 306-410, Qty 18; For use with the Stryker PCD Precision System and ACM Deliv
FDA device recall Z-1193-2008 · posted 2008-03-11 · Terminated
Recall details
- Recalling firm
- Stryker Instruments Div. of Stryker Corporation
- Reason for recall
- Mis-labeling; The instructions for use include a use for which the device is not intended. (Device not approved to capture a bone biopsy)
- Action taken
- 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.
- Root cause
- Labeling Change Control
- Status
- Terminated
- Product code
- JDZ
- Quantity affected
- 953 boxes Recalls Z-1192-1195-2008
- Distribution
- Nationwide.
- Date initiated
- 2008-02-13
- Date posted
- 2008-03-11
- Date terminated
- 2008-12-30
- Location
- Portage, MI
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