Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0444-2018·Announced 2018-02-07

Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Assembly Defect

Zimmer Biomet is recalling 638 units of Affixus Hip Fracture Nails because a manufacturing defect may prevent proper assembly of the device.

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, and the defect is a manufacturing/assembly issue that prevents proper device assembly rather than a direct patient safety hazard like a fracture or infection. No injuries or illnesses are reported in the source text.

Plain-English summary

Zimmer Biomet, Inc. is recalling 638 units of the Affixus Hip Fracture Nail, LH 130 DEG 9MM X 340MM. The recall was initiated after it was detected during a rework process for a previous field action that the set screw and sleeve assembly were no longer in the installed location. These components are designed to have an interference fit, and their displacement could prevent the product from being properly assembled with the mating screw and targeting jig.

The affected product was distributed nationwide in the United States, as well as in Portugal and the Netherlands. The specific item number is 814609340, and the lot number is 535230 with an expiration date of 05/24/2027. The Unique Device Identifier (UDI) is (01)00887868039690 (17)270524 (10)535230.

Healthcare providers and facilities should check their inventory for this specific lot and item number. If the product is found, it should be removed from use and returned to Zimmer Biomet, Inc. according to the company's instructions. This recall is classified as Class II by the FDA, indicating that use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product: Affixus Hip Fracture Nail, LH 130 DEG 9MM X 340MM
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. 814609340

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