Recall Z-1721-2015 ยท HSB Rod, Fixation, Intramedullary And Accessories
Vilex In Tennessee Inc
Vilex, Inc., FUZE 10.0 mm x 150 mm, Product # FZ100-150T-25. Ankle arthrodesis, tibio-talo-calcaneal arthrodesis.
| Date | Jun 8, 2015 (initiated Apr 22, 2015) |
| Status | Terminated |
| Reason | Incidence of breakage is higher than expected. |
| Root cause | Device Design |
| Action | The initial telephone call (4/9/2015) informed the distributor that the product was on hold (not to be used or transferred). The second telephone call (4/29/2015) and letter informed the customer that the product was being removed from market and that the customer was to return the product to the corporate office. The letter was disseminated on 05/05/2015 to distributors via certified mail. The letter contains the instructions for them to follow, which as summarized are: inventory all products on hand, sign off on inventory sheet, send products back to the corporate office with the identifi |
| Quantity | 13 units |
| Distribution | Distributed in the states of MS, MD, PA, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102413 | FUZE: INTRAMEDULLARY INTERNAL FIXATION NAIL Vilex, Inc., Nov 14, 2011 |