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

Recall date

April 17, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2215-2017

FDA classification

Class II

Brand / firm

Zimmer Biomet, Inc.

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.