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.
FDA Recall Z-0289-2009 · Posted 2008-11-21
Recalling FirmBiomet, Inc.
Recall StatusTerminated
Product CodeJWH
Date Initiated2008-09-22
Date Terminated2009-09-22
Product Quantity11
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".
Firm Action
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).
Root Cause
Process control
Distribution Pattern
Worldwide Distribution: USA including states of Florida, New Jersey, Maryland, Pennsylvania, South Carolina, South Dakota, and Virginia, and country of Finland.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.