Zimmer Biomet, Inc.: Medical Device Recall in 2018 - (Recall #: Z-1234-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

ACE Trochanteric Nail System ATN LAG SCREW 60MM STERILE ATN LAG SCREW 65MM STERILE ATN LAG SCREW 70MM STERILE ATN LAG SCREW 75MM STERILE ATN LAG SCREW 80MM STERILE ATN LAG SCREW 85MM STERILE ATN LAG SCREW 90MM STERILE ATN LAG SCREW 95MM STERILE ATN LAG SCREW 100MM STERILE ATN LAG SCREW 105MM STERILE ATN LAG SCREW 110MM STERILE ATN LAG SCREW 115MM STERILE ATN LAG SCREW 120MM STERILE ATN LAG SCREW 125MM STERILE ATN LAG SCREW 130MM 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.

Product Classification:

Class II

Date Initiated: December 20, 2017

Date Posted: April 4, 2018

Recall Number: Z-1234-2018

Event ID: 79408

Reason for Recall:

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.

Status: Terminated

Product Quantity: 3454

Code Information:

903311060 903311065 903311070 903311075 903311080 903311085 903311090 903311095 903311100 903311105 903311110 903311115 903311120 903311125 903311130

Distribution Pattern:

USA (nationwide)

Voluntary or Mandated:

Voluntary: Firm initiated