Recalls / —
—#68287
Product
Stryker VertePort , 11 G Cement Cannula, REF 306-510 , Qty 18; For use with the Stryker PCD Precision System and ACM Delivery System, Rx only, sterile, Stryker Instruments, Kalamazoo, MI.
- FDA product code
- JDZ — Mixer, Cement, For Clinical Use
- Device class
- Class 1
- Medical specialty
- Orthopedic
- Affected lot / code info
- All Lots-BB43, BDL5, BE0M, BE1D, BE77, BF4K, BMWJ, BNW8, BNW9 and BQ5W
Why it was recalled
Mis-labeing; The instructions for use include a use for which the device is not intended. (Device not approved to capture a bone biopsy)
Root cause (FDA determination)
Labeling Change Control
Action the firm took
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.
Recalling firm
- Firm
- Stryker Instruments Div. of Stryker Corporation
- Address
- 4100 E Milham Ave, Portage, Michigan 49002-9704
Distribution
- Distribution pattern
- Nationwide.
Timeline
- Recall initiated
- 2008-02-13
- Posted by FDA
- 2008-03-11
- Terminated
- 2008-12-30
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #68287. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.