UC Tibial Insert, Size 4, 12mm, REF 163-3412, Sterile R, Ortho Development, Draper, Utah 84020 The tibial insert is a device that fits into the tibial tray during knee revision. It provides the base for the metal femoral portion of the system, and moderates the degree of flexion afforded by the procedure.
This recall has been terminated (originally issued January 7, 2011).
- Company
- Ortho Development Corporation
- Recall Initiated
- January 7, 2011
- Terminated
- December 27, 2011
- Recall Number
- Z-1742-2011
- Quantity
- 33 units (US)
- Firm Location
- Draper, UT
- Official Source
- View on FDA website ↗
Reason for Recall
Components of a replacement knee system could be mislabeled.
Distribution
Worldwide distribution: USA including states of: AZ, CA, FL, MI, TX, and UT; and country of: Japan.
Lot / Code Info
Lot Number: 670676
Root Cause
Error in labeling
Action Taken
The firm, Ortho Development, sent a "Field Notification Memo" date January 7, 2011 to its customers. The memo described the product, problem and action to be taken. The customers were instructed to promptly return any remaining parts of the listed product; locate all the parts in their inventory; identify any of the listed parts that may have been used in surgery; verify the quantity they have on hand and the quantity used in surgery and reconcile them with the quantity sent; if discrepancy exists, notify customer service resolution; prepare items for return and contact customer service to obtain RMA number. Once reconciled, arrangements would be made for sending new inventory and the return of unused parts. If you have any questions regarding this issue, please notify Regulatory Affairs Manager at (801) 619-3450.