Zimmer Biomet, Inc.: Medical Device Recall in 2018 - (Recall #: Z-1227-2018)

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 STER TROC NAIL 125 DEG X 9MM STER TROC NAIL 130 DEG X 9MM STER TROC NAIL 135 DEG X 9MM 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-1227-2018

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:

903209125 903209130 903209135

Distribution Pattern:

USA (nationwide)

Voluntary or Mandated:

Voluntary: Firm initiated