AFFIXUS Hip Fracture Nail Product Usage: The Hip Fracture Nail System… — Class II medical device recall Z-2215-2017
Terminated recall by Zimmer Biomet, Inc., reported 2017-06-07, distributed nationwide. nail not properly engaging with the targeting jig due to certain undersized specification
| Recall number | Z-2215-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2017-04-17 |
| Classified | 2017-06-01 |
| Reported by FDA | 2017-06-07 |
| Terminated | 2019-08-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, CH, CL, CO, CR, ES, GB, JP, NL |
| Quantity | 33,500 |
| Lot numbers | DLBH21, DLFB60, DLFB61, DLFB62, DLFB63, DLFB64, DLFB65, DLFB66, DLFB67, DLFB68, DLFB69, DLFB6Z, DLFB77, DLFB7B, DLFB7C, DLFB7D, DLFB7F, DLFB7G, DLFB7H, DLFB7J, DLFB7K, DLFB7L, DLFB7M, DLFB7N, DLFB7P, DLFB7R, DLFB7T, DLFB7V, DLFB7W, DLFB7Y, DLFB7Z, DLFBB0, DLFBB1, DLFBB2, DLFBB3, DLFBB4, DLFBB5, DLFBB6, DLFBB7, DLFBB8 and 1 more |
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 for recall
nail not properly engaging with the targeting jig due to certain undersized specification
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2215-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.