Recall Z-1741-2015 ยท KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Biomet, Inc.
Unilateral external fixation ankle clamp Product Usage: Unilateral external fixation for use treatment of bone conditions amenable to treatment by use of external fixation modality
| Date | Jun 9, 2015 (initiated May 1, 2015) |
| Status | Terminated |
| Reason | Ankle clamp was assembled incorrectly; the offset of the pin to the pivot point is reversed. This prevents complete range of motion and if pushed too far may loosen the pin from the bone. A revision surgery may be necessary to adequately reconnect the fixator to the bone. |
| Root cause | Process control |
| Action | Biomet sent an URGENT MEDICAL DEVICE RECALL NOTICE letter dated May 1, 2015 to the affected distributors and implanting surgeons. The recall letter included a description of the reason for the recall, affected product, consignee responsibilities, and distributor instructions for responding to the formal recall notification. Consignees were instructed to return the affected product and continued monitoring of patients. Questions related to this notice should be directed to (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m. |
| Quantity | 19 |
| Distribution | US Nationwide Distribution in the states of CA, TX, FL, NC, MI, GA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111376 | CONSTRUX EXTERNAL FIXATION DEVICE Ebi, LLC, Aug 3, 2011 |