Biomet OSS (Orthopedic Salvage System) RS Non-Modular Long Tibial Base, 75mm x 10 x 160mm, Co-CR-MO/Ti-6AL-4V alloy, ste
FDA device recall Z-2214-2008 · posted 2008-09-17 · Terminated
Recall details
- Recalling firm
- Biomet, Inc.
- Reason for recall
- Mislabeled as to size: Product is labeled as reduced size, but is actually standard size.
- Action taken
- Consignees were notified by an Urgent Medical Device Recall Notice letter dated 11/7/07. The letter required that use of the product be immediately discontinued and that components be returned to Biomet. Letters to hospital administrators and the five implanting surgeons were issued on/or about 5/6/08 advising them of the problem and to perform patient evaluations.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- JDI
- Quantity affected
- 22
- Distribution
- Nationwide Distribution --- including states of California, Florida, Illinois, Indiana, Massachusetts, Missouri, New Jersey, Oklahoma, Pennsylvania, Texas, Virginia and Washington.
- Date initiated
- 2007-11-07
- Date posted
- 2008-09-17
- Date terminated
- 2009-03-13
- 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 |
|---|---|---|
| ORTHOPEDIC SALVAGE SYSTEM- OSS (K052685) | Biomet, Inc. | 2005-10-27 |