Biomet Vanguard(TM) DCM PS Plus 16mm x 63/67mm Tibial Bearing (REF. 183726), ARCOM UHMWPE, sterile, Biomet Orthopedics, Inc., Warsaw, IN. A knee prosthesis intended for single use implantation to replace the articular portions of the knee joint.
This recall has been terminated (originally issued November 21, 2008).
- Company
- Biomet, Inc.
- Recall Initiated
- September 22, 2008
- Posted
- November 21, 2008
- Terminated
- September 22, 2009
- Recall Number
- Z-0289-2009
- Quantity
- 11
- Firm Location
- Warsaw, IN
- Official Source
- View on FDA website ↗
Reason for Recall
The package is properly labeled, but the laser etch for size incorrectly reads "16 X 63/63" instead of the correct size, "16 X 63/67".
Distribution
Worldwide Distribution: USA including states of Florida, New Jersey, Maryland, Pennsylvania, South Carolina, South Dakota, and Virginia, and country of Finland.
Lot / Code Info
Lots 713910, 806560, 816560 and 871750.
Root Cause
Process control
Action Taken
A notification letter (Urgent Medical Device Removal Notice) dated 9/22/08 was sent to the firm's sales staff with instructions to locate and retrieve the product and to notify customers at affected hospitals of the problem. Questions related to this notice should be directed to the Biomet Orthopedics, LLC Corrective Actions Manager at 800-348-9500 or 574-372-3983, Monday through Friday, 8 A.M. to 5 P.M. (EST).