Recall Z-2215-2017— Zimmer Biomet, Inc.

Name: FDA recall Z-2215-2017
Creator: U.S. Food and Drug Administration
Published: 2017-04-17

Class II · Terminated

Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2017-04-17, terminated 2019-08-06. It names one FDA 510(k) clearance: K100238. 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.

Recalling firm: Zimmer Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-04-17
Terminated: 2019-08-06
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K100238 — HFN 125 DEGREE 9-13 MM, 180MM, HFN 130 DEGREE 9-13 MM, HFN RH 125 DEGREE 9-13MMDePuy Orthopaedics, Inc.·cleared 2010-05-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.