Biomet Vanguard(TM) DCM PS Plus 16mm x 63/67mm Tibial Bearing (REF. 183726), ARCOM UHMWPE, sterile, Biomet Orthopedics,
FDA device recall Z-0289-2009 · posted 2008-11-21 · Terminated
Recall details
- Recalling firm
- Biomet, Inc.
- 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".
- 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).
- Root cause
- Process control
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 11
- Distribution
- Worldwide Distribution: USA including states of Florida, New Jersey, Maryland, Pennsylvania, South Carolina, South Dakota, and Virginia, and country of Finland.
- Date initiated
- 2008-09-22
- Date posted
- 2008-11-21
- Date terminated
- 2009-09-22
- Location
- Warsaw, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MAXIM ACCEL (VANGUARD) PS+ BEARINGS (K041046) | Biomet, Inc. | 2004-05-21 |