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Zimmer Biomet, Inc. recalls ACE Trochanteric Nail System ATN AR SCREW 60MM STERILE ATN AR SCREW 65MM STERILE ATN AR SCREW 70MM STERILE ATN AR SC
Recalled April 4, 2018 · FDA recall Z-1233-2018 · Zimmer Biomet
Hazard
Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to the acceptance criteria for the DPR protocol for the ATN system. · FDA Class II
Units
3454
Sold at
USA (nationwide)
Description
Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to the acceptance criteria for the DPR protocol for the ATN system.
Product
ACE Trochanteric Nail System ATN AR SCREW 60MM STERILE ATN AR SCREW 65MM STERILE ATN AR SCREW 70MM STERILE ATN AR SCREW 75MM STERILE ATN AR SCREW 80MM STERILE ATN AR SCREW 85MM STERILE ATN AR SCREW 90MM STERILE ATN AR SCREW 95MM STERILE ATN AR SCREW 100MM STERILE The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures. The Trochanteric Long Nail System is additionally indicated to treat pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fractures, ipsilateral femoral fractures, proximal or distal nonunions and malunions and revision procedures.
Manufacturer(s)
Zimmer Biomet, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →