PlainRecalls
FDA Devices Moderate Class II Terminated

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 p

Reported: June 7, 2017 Initiated: April 17, 2017 #Z-2215-2017

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

Details

Recalling Firm
Zimmer Biomet, Inc.
Units Affected
33,500
Distribution
Worldwide - US Nationwide and the countries of AUSTRALIA, CANADA, CHILE, COLOMBIA, COSTA RICA, NETHERLANDS, JAPAN, SPAIN AND CANARY ISLANDS, SWITZERLAND and UNITED KINGDOM.
Location
Warsaw, IN

Frequently Asked Questions

What product 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.. Recalled by Zimmer Biomet, Inc.. Units affected: 33,500.
Why was this product recalled? ▼
nail not properly engaging with the targeting jig due to certain undersized specification
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 7, 2017. Severity: Moderate. Recall number: Z-2215-2017.

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