Agency classClass IIOur severity:High FDA (Devices)·Z-1229-2018·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, and the hazard involves a structural failure of an orthopedic implant (survivorship failure) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Zimmer Biomet, Inc. is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system. The recall involves specific Trochanteric Nail System kits, including models TROCH NAIL ST 11X180 125DG STRL, TROCH NAIL ST 11X180 130DG STRL, and TROCH NAIL ST 11X180 135DG STRL. The product is 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 the number of affected units, the distribution scope, or any reported injuries or illnesses.

Healthcare providers and patients should contact Zimmer Biomet for further instructions regarding the recall. The source text does not provide specific consumer action steps beyond the general recall notice.

The recalled product

Product: ACE Trochanteric Nail System TROCH NAIL ST 11X180 125DG STRL TROCH NAIL ST 11X180 130DG STRL TROCH NAIL ST 11X180 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 Implant
Hazard: structural-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)

903211125 903211130 903211135

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 →

High
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FDA (Devices) · 2020-12-30
Moderate
Zimmer Biomet Recalls Polaris Spinal System Screws for Labeling Update
FDA (Devices) · 2020-12-23
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 · structural failure