FDA-Device2018-04-04Class II

ACE Trochanteric Nail System ACE TROCH NAIL 125 DEG. X 11MM ACE TROCH NAIL 130 DEG. X 11MM ACE TROCH NAIL 135 DEG. X 11MM ACE TROCH NAIL 125 DEG. X 13MM ACE TROCH NAIL 130 DEG. X 13MM ACE TROCH NAIL 135 DEG. X 13MM 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 add

Zimmer Biomet, Inc.

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.

Sold states

USA (nationwide)

Affected count

3454

Manufactured in

56 E Bell Dr, Warsaw, IN, United States

Products

ACE Trochanteric Nail System ACE TROCH NAIL 125 DEG. X 11MM ACE TROCH NAIL 130 DEG. X 11MM ACE TROCH NAIL 135 DEG. X 11MM ACE TROCH NAIL 125 DEG. X 13MM ACE TROCH NAIL 130 DEG. X 13MM ACE TROCH NAIL 135 DEG. X 13MM 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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1225-2018

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