Biomet 2.0 MM Stainless Steel (SS) Crimp Sleeve, sterile, use w/2.0 MM S.S. cable # 350800, Biomet Orthopedics, Inc., Wa
FDA device recall Z-0288-2009 · posted 2008-11-09 · Terminated
Recall details
- Recalling firm
- Biomet, Inc.
- Reason for recall
- The outer package is properly labeled, but the inner package may be labeled as a femoral component.
- Action taken
- The firm's sales force was notified of the problem via an Urgent Medical Device Removal Notice letter dated 9/24/08, and provided instructions to retrieve the product from customer accounts and to provide them with a copy of the removal letter. Distributors were to immediately locate and remove the identified implants from circulation, carefully follow the instructions, and fax a copy of the Response Form prior to the return of the product. If the product was further distributed, hospital personnel MUST be notified via the enclosed "Dear Biomet Customer" notice. The letter MUST be given to hospital personnel responsible for receiving recall notices but distributors are charged with the location and return of those products.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- JDQ
- Quantity affected
- 48
- Distribution
- Worldwide Distribution --- USA including states of Arkansas, Florida, Kansas, New Jersey, and Ohio, and countries of Argentina, Canada, Chile Italy, Mexico and United Kingdom.
- Date initiated
- 2008-09-24
- Date posted
- 2008-11-09
- Date terminated
- 2009-06-29
- 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 |
|---|---|---|
| BMP CABLE SYSTEM (K982545) | Biomet, Inc. | 1998-10-19 |