Biomet Vanguard DCM CR Tibial Bearing, 14MM x 79/83MM, CR STD bearing, sterile, Biomet Orthopedics, Inc., Warsaw, IN; Pa
FDA device recall Z-1376-2008 · posted 2008-07-25 · Terminated
Recall details
- Recalling firm
- Biomet, Inc.
- Reason for recall
- Mislabeled: The packaging of the two products was mixed up, resulting in the products being labeled with an incorrect size. If implanted, the product may not fit properly, which could require repeat surgery. The problem could also result in a delay in the procedure.
- Action taken
- Distributors were notified via recall letter (Urgent Medical Device Removal Notice) dated 2/12/08 to locate the devices in their possession and at hospital sites, discontinue use, and return them to Biomet. Hospitals having received the devices will be provided with a recall letter dated 2/12/08 which describes the nature of the problem and the removal of these instruments. A third letter dated 2/12/08 was provided for implanting physicians.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 8
- Distribution
- Worldwide: USA and Australia
- Date initiated
- 2008-02-12
- Date posted
- 2008-07-25
- Date terminated
- 2009-12-22
- 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 KNEE SYSTEM (K023546) | Biomet, Inc. | 2003-01-17 |