Agency classClass IIOur severity:High FDA (Devices)·Z-1231-2018·Announced 2018-04-04

Zimmer Biomet Recalls ACE Trochanteric Nail System Due to Performance Failure

Zimmer Biomet is recalling the ACE Trochanteric Nail System because a Device Performance Review failed clinical analysis for survivorship.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The source text does not report any hospitalizations, injuries, or deaths, and the hazard is a performance failure (survivorship) rather than a high-risk pathogen or structural defect with reported harm, placing it in the High category per the rubric.

Plain-English summary

Zimmer Biomet, Inc. is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system. The recall involves 3,454 units of the system, which is intended to treat stable and unstable proximal fractures of the femur, including pertrochanteric and intertrochanteric fractures.

The recall was initiated after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to the acceptance criteria for the DPR protocol for the ATN system. The affected product codes are 903213125, 903213130, and 903213135.

The recall is classified as Class II by the FDA. The distribution pattern is listed as USA (nationwide). The source text does not specify specific actions for consumers or patients, nor does it report any specific injuries or illnesses associated with the device.

The recalled product

Product: ACE Trochanteric Nail System TROCH NAIL ST 13X180 125DG STRL TROCH NAIL ST 13X180 130DG STRL TROCH NAIL ST 13X180 135DG STRL The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures…
Manufacturer: Zimmer Biomet, Inc.
Category: Medical Device — Orthopedic Implants
Hazard: device-performance-failure
Affected units: 3,454

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

903213125 903213130 903213135

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 11 recalled by Zimmer Biomet, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 11 products in this recall →

Same manufacturer · Zimmer Biomet, Inc.

See all →

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High
Zimmer Biomet Recalls Hip Prosthesis Cups Due to Sterilant Biocompatibility Concerns
FDA (Devices) · 2020-11-11
High
Zimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns
FDA (Devices) · 2020-11-11
High
Zimmer Biomet Recalls Hip Prosthesis Component Due to Sterilant Concerns
FDA (Devices) · 2020-11-11

Same hazard · device performance failure