Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0481-2018·Announced 2018-02-07

Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect

Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing rework error may have displaced internal components, potentially preventing proper assembly.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The hazard is a manufacturing defect that prevents proper assembly of the device, which is a significant quality issue but does not involve reported injuries, deaths, or high-risk pathogens, fitting the criteria for a moderate severity score.

Plain-English summary

Zimmer Biomet, Inc. is recalling 638 units of the Affixus Hip Fracture Nail, RH 130 DEG 9MM X 380MM (Item No. 814509380). The affected lots are 507130, 892880, and 893400. These medical devices were distributed nationwide in the United States, as well as in Portugal and the Netherlands.

The recall was initiated after it was detected during a rework process for a previous field action that the set screw and sleeve assembly, which are designed to have an interference fit, were no longer in their installed location. This defect could prevent the product from being properly assembled with the mating screw and targeting jig.

Healthcare providers and facilities that have received these specific lots should stop using the affected devices and contact Zimmer Biomet for instructions on return or replacement. Consumers should not attempt to use these orthopedic implants independently, as they are intended for professional surgical use.

The recalled product

Product: Affixus Hip Fracture Nail, RH 130 DEG 9MM X 380MM
Manufacturer: Zimmer Biomet, Inc.
Category: Medical Device — Orthopedic Implant
Hazard: manufacturing-defect
assembly-failure
Affected units: 638

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 (3)

Item No. 814509380
892880 (06/13/2027) UDI (01)00887868038914 (17)270613 (10)892880
893400 (06/13/2027) UDI (01)00887868038914 (17)270613 (10)893400

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 65 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 65 products in this recall →

Same manufacturer · Zimmer Biomet, Inc.

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Zimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns
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Same hazard · manufacturing defect