FDA Recall
Terminated
Cancellous Bone Screw, 6.5 x 50 mm, Model 0214807
Recall: Z-0924-05
·
Initiated June 3, 2005
Recall
- Recall Number
- Z-0924-05
- Event Number
- 32337
- Firm
- Plus Orthopedics USA
- FEI Number
- 3001237832
- Product Code
- JWH
- Status
- Terminated
- Root Cause
- Other
- Initiated
- June 3, 2005
- Posted
- June 22, 2005
- Terminated
- July 13, 2005
- Address
- 10188 Telesis Ct, San Diego, CA, 92121-4779
Description
Cancellous Bone Screw, 6.5 x 50 mm, Model 0214807
Reason
Screw is mislabeled as a 50 mm screw when in fact it is 45 mm long.
Action
Notification was made by telephone beginning June 2, 2005. Recall is on-going.
Distribution
Idaho, Texas and Virginia
Quantity
54 USA 78 Europe