Stryker VertePort, 10 G Cement Cannula, REF 306-410, Qty 18; For use with the Stryker PCD Precision System and ACM Delivery System, Rx only, sterile, Stryker Instruments, Kalamazoo, MI.
FDA Recall Z-1193-2008 · Posted 2008-03-11
Recalling FirmStryker Instruments Div. of Stryker Corporation
Recall StatusTerminated
Product CodeJDZ
Date Initiated2008-02-13
Date Terminated2008-12-30
Product Quantity953 boxes Recalls Z-1192-1195-2008
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)
Firm 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.
Root Cause
Labeling Change Control
Distribution Pattern
Nationwide.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.