Recall Z-2215-2017 ยท HSB Rod, Fixation, Intramedullary And Accessories
Zimmer Biomet, Inc.
AFFIXUS Hip Fracture Nail Product Usage: The Hip Fracture Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, interochanteric fractures, high subtrochanteric fractures and combinations of these fractures, including non-union, malunion and tumor resections. The Long Nail system is additionally indicated to treat pertrochanter
| Date | Apr 17, 2017 |
| Status | Terminated |
| Reason | nail not properly engaging with the targeting jig due to certain undersized specification |
| Root cause | Process control |
| Action | On 4/17/2017, URGENT MEDICAL DEVICE RECALL REMOVAL Lot Specific notifications were sent to the affected consignees via traceable methods. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. |
| Quantity | 33,500 |
| Distribution | Worldwide - US Nationwide and the countries of AUSTRALIA, CANADA, CHILE, COLOMBIA, COSTA RICA, NETHERLANDS, JAPAN, SPAIN AND CANARY ISLANDS, SWITZERLAND and UNITED KINGDOM. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K100238 | HFN 125 DEGREE 9-13 MM, 180MM, HFN 130 DEGREE 9-13 MM, HFN RH 125 DEGREE 9-13MM DePuy Orthopaedics, Inc., May 11, 2010 |