Biomet OSS FINN Proximal Femoral Trial 7 cm resection/right, stainless steel, Biomet Orthopedics, Inc., Warsaw, IN; REF
FDA device recall Z-1526-2009 · posted 2009-06-29 · Terminated
Recall details
- Recalling firm
- Biomet, Inc.
- Reason for recall
- The retaining ring may fall out of the instrument during surgery.
- Action taken
- Distributors and consignees were notified by an Urgent Medical Device Recall Notice dated 5/19/09. Distributors and consignees were instructed to locate and remove the devices from circulation, carefully follow the instructions on the "FAX Back Response Form," and fax a copy of the Response Form to 574-372-1683 prior to return of the product. If the product has been further distributed, consignees must notify hospital personnel responsible for receiving recall notices of the action, via the enclosed "Dear Biomet Customer" notice. Consignees are responsible for the location and return of products to the firm. The letter stated that the instruments would be reworked and returned.
- Root cause
- Process control
- Status
- Terminated
- Product code
- KRO
- Quantity affected
- 387 of all products
- Distribution
- Worldwide Distribution -- USA, Australia, Belgium, Canada, Costa Rica, Finland, France, Germany, Mexico, New Zealand, Poland, South Wales, and Spain.
- Date initiated
- 2009-05-19
- Date posted
- 2009-06-29
- Date terminated
- 2010-10-08
- 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 |
|---|---|---|
| COMPRESS SEGMENTAL FEMORAL REPLACEMENT SYSTEM (K043547) | Biomet, Inc. | 2005-08-05 |
| ONCOLOGY SALVAGE SYSTEM (K002757) | Biomet, Inc. | 2000-11-24 |