EBI XFIX DFS Rail System (Adult Rail Gradual Swivel Clamp). The Biomet Rail System consists of a unilateral external fix
FDA device recall Z-0527-2013 · posted 2012-12-17 · Terminated
Recall details
- Recalling firm
- Biomet, Inc.
- Reason for recall
- It was reported that the number scale/graduation markings were missing on 14 pieces of the swivel clamp.
- Action taken
- On 11/9/2012 an URGENT MEDICAL DEVICE RECALL NOTIFICATION letter was sent to all consignees (distributors and Doctor notices) informing them of the issue and providing recommended actions. Customer contact number (574) 372-1570 Monday through Friday from 8 am to 5 pm.
- Root cause
- Process design
- Status
- Terminated
- Product code
- KTT
- Quantity affected
- 49
- Distribution
- Worldwide Distribution, including the states of TX, TN, PA, CA, NY, FL, and MI and the countries of Japan and Columbia.
- Date initiated
- 2012-11-09
- Date posted
- 2012-12-17
- Date terminated
- 2013-08-28
- 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 |
|---|---|---|
| EBI XFIX DFS RAIL SYSTEM (K000083) | Ebi, L.P. | 2000-02-03 |