Z-0924-05
Cancellous Bone Screw, 6.5 x 50 mm, Model 0214807
Plus Orthopedics / initiated 2005-06-03 / Terminated / root cause: labeling and UDI
Plus Orthopedics USA began a recall of Cancellous Bone Screw, 6.5 x 50 mm, Model 0214807 on . The reason FDA records is "Screw is mislabeled as a 50 mm screw when in fact it is 45 mm long". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.
Recall record
- Recall number
- Z-0924-05
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Plus Orthopedics
- Product
- Cancellous Bone Screw, 6.5 x 50 mm, Model 0214807
- Product code
- JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- Reason for recall
- Screw is mislabeled as a 50 mm screw when in fact it is 45 mm long.
- Root cause tag
- labeling and UDI
- FDA root cause
- Other
- Action
- Notification was made by telephone beginning June 2, 2005. Recall is on-going.
- Quantity in commerce
- 54 USA 78 Europe
- Distribution
- Idaho, Texas and Virginia
- Product codes and lots
- Lot / Unit Code: 044152
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