Agency classClass IIOur severity:High FDA (Devices)·Z-1234-2018·Announced 2018-04-04

Zimmer Biomet Recalls ACE Trochanteric Nail System Due to Performance Failure

Zimmer Biomet is recalling the ACE Trochanteric Nail System after 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 and involves a structural failure (survivorship) in a load-bearing orthopedic implant, which poses a risk of harm, but no specific injuries or illnesses are reported in the source text.

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 ATN LAG SCREW in various sterile sizes, ranging from 60mm to 130mm. These devices are intended to treat stable and unstable proximal fractures of the femur, including pertrochanteric, intertrochanteric, and high subtrochanteric 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 source text does not specify reported injuries, illnesses, or specific distribution dates beyond the nationwide distribution in the USA.

Healthcare providers and patients should contact Zimmer Biomet for further instructions regarding the return or replacement of these devices. The recall is classified as Class II by the FDA.

The recalled product

Product: 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…
Manufacturer: Zimmer Biomet, Inc.
Category: Medical Device — Orthopedic Implants
Hazard: structural-failure
implant-failure
Affected units: 3,454

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
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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 · structural failure