FDA Device recall Z-2215-2017
AFFIXUS Hip Fracture Nail Product Usage: The Hip Fracture Nail System is intended to treat stable and unstable proximal fractures of the fe…
- FDA Device
- Class II
- terminated
- Published 2017-06-07
On 2017-06-07 the FDA classified a Class II recall of AFFIXUS Hip Fracture Nail Product Usage: The Hip Fracture Nail System is intended to treat stable and unstable proximal fractures of the fe… by Zimmer Biomet, citing nail not properly engaging with the targeting jig due to certain undersized specification.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2215-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-04-17 |
| Published | 2017-06-07 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Zimmer Biomet |
| Distribution | US |
Product
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 pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone (including prophylactic use) of the trochanteric and diaphyseal areas, impending pathological fractures, long subtrochanteric fractures, ipsilateral femoral fractures, proximal or distal non-unions, malunions, revision procedures and tumor resections.
Reason
nail not properly engaging with the targeting jig due to certain undersized specification
Identifiers
| code_info | LOT DLBH21 DLFB60 DLFB61 DLFB62 DLFB63 DLFB64 DLFB65 DLFB66 DLFB67 DLFB68 DLFB69 DLFB6Z DLFB77 DLFB7B DL…LOT DLBH21 DLFB60 DLFB61 DLFB62 DLFB63 DLFB64 DLFB65 DLFB66 DLFB67 DLFB68 DLFB69 DLFB6Z DLFB77 DLFB7B DLFB7C DLFB7D DLFB7F DLFB7G DLFB7H DLFB7J DLFB7K DLFB7L DLFB7L DLFB7M DLFB7N DLFB7P DLFB7R DLFB7T DLFB7V DLFB7W DLFB7Y DLFB7Z DLFBB0 DLFBB1 DLFBB2 DLFBB3 DLFBB4 DLFBB5 DLFBB6 DLFBB7 DLFBB8 DLFBB9 DLFBBW DLFBBY DLFBBZ DLFBCB DLFBCC DLFBCD DLFBDG DLFBDH DLFBDJ DLFBDJ DLFBDK DLFBDL DLFBDM DLFBDN DLFBDP DLFBDR DLFBDT DLFBDV DLG DLGB70 DLGB71 DLGB72 DLGB73 DLGB74 DLGB75 DLGB76 DLGB77 DLGB78 DLGB79 DLGB7C DLGB7D DLGB7P DLGB7R DLGB7T DLGB7V DLGB7W DLGB7Y DLGB7Z DLGB8 DLGB80 DLGB81 DLGB82 DLGB83 DLGB84 DLGB85 DLGB86 DLGB87 DLGB88 DLGB89 DLGB8B DLGB8C DLGB8D DLGB8F DLGB8G DLGB8H DLGB8J DLGB8K DLGB8L DLGB8M DLGB8N DLGB8P DLGB8R DLGB8R DLGB8T DLGB8V DLGB8W DLGB8Y DLGB8Z DLGB9B DLGB9C DLGB9D DLGB9F DLGB9G DLGB9H DLGB9J DLGB9K DLGB9L DLGB9M DLGB9N DLGBC DLGBC0 DLGBC1 DLGBC3 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2215-2017%22
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