Zimmer Biomet, Inc. recalls AFFIXUS Hip Fracture Nail Product Usage: The Hip Fracture Nail System is intended to treat stable and unstable proxi

Recalled June 7, 2017 · FDA recall Z-2215-2017 · Zimmer Biomet

Hazard

nail not properly engaging with the targeting jig due to certain undersized specification · FDA Class II

Units

33,500

Sold at

Worldwide - US Nationwide and the countries of AUSTRALIA, CANADA, CHILE, COLOMBIA, COSTA RICA, NETHERLANDS, JAPAN, SPAIN AND CANARY ISLANDS, SWITZERLAND and UNITED KINGDOM.

Description

nail not properly engaging with the targeting jig due to certain undersized specification

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.

Manufacturer(s)

Zimmer Biomet, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →