Recall Z-0527-2013 ยท KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Biomet, Inc.
EBI XFIX DFS Rail System (Adult Rail Gradual Swivel Clamp). The Biomet Rail System consists of a unilateral external fixator rail, modular bone screw clamps, and compression and distraction units. The device is used in the treatment of bone fractures.
| Date | Dec 17, 2012 (initiated Nov 9, 2012) |
| Status | Terminated |
| Reason | It was reported that the number scale/graduation markings were missing on 14 pieces of the swivel clamp. |
| Root cause | Process design |
| Action | 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. |
| Quantity | 49 |
| Distribution | Worldwide Distribution, including the states of TX, TN, PA, CA, NY, FL, and MI and the countries of Japan and Columbia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K000083 | EBI XFIX DFS RAIL SYSTEM Ebi, L.P., Feb 3, 2000 |