Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0471-2018·Announced 2018-02-07

Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Assembly Defect

Zimmer Biomet is recalling 638 units of the Affixus Hip Fracture Nail because a manufacturing rework process caused set screws and sleeves to shift, 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, which is a significant quality issue but does not explicitly report injuries, deaths, or high-risk biological 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 11MM X 440MM. The affected product is identified by Item No. 814511440 and Lot No. 507320, with an expiration date of May 21, 2027. The recall covers units 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 should stop using the affected devices and contact Zimmer Biomet for instructions on how to return or dispose of the product. Patients who have already received the implant should contact their healthcare provider to discuss the findings and determine if any further action is necessary.

The recalled product

Product: Affixus Hip Fracture Nail, RH 130 DEG 11MM X 440MM
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 (1)

Item No. 814511440

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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Same hazard · manufacturing defect