Agency classClass IIOur severity:High FDA (Devices)·Z-0454-2019·Announced 2018-11-21

Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Set Screw Issue

Zimmer Biomet is recalling 2,163 Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.

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. The hazard involves a functional defect in a medical device used for fracture stabilization, which poses a risk of harm if the device fails to function as intended, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Zimmer Biomet, Inc. is recalling 2,163 units of the Affixus Hip Fracture Nail 130 Deg 12x165mm (Item Number 816812165). The recall involves Lot number 901770. The Affixus Hip Fracture Nail System is an intramedullary hip screw used by surgeons to stabilize fractures of the proximal femur.

The recall was initiated because the set screw is not able to advance or reverse from the original position in the nail. This functional defect may prevent proper surgical stabilization of the hip fracture.

The affected devices were distributed nationwide in the United States to 40 states and Puerto Rico, as well as to Chile, Costa Rica, Ecuador, and the Netherlands. Healthcare providers and facilities should contact Zimmer Biomet for instructions on how to handle the affected devices.

The recalled product

Product: Affixus Hip Fracture Nail 130 Deg 12x165mm, Item Number 816812165 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabilize fractures of the proximal femur.
Manufacturer: Zimmer Biomet, Inc.
Category: Medical Device — Orthopedic Implant
Hazard: mechanical-failure
Affected units: 2,163

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)

Lot number 901770

Distribution

Distributed nationwide across the United States.

The notice also names 41 states specifically:

Part of a larger recall action

This product is one of 8 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 8 products in this recall →

Same manufacturer · Zimmer Biomet, Inc.

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Zimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns
FDA (Devices) · 2020-11-11
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Zimmer Biomet Recalls Hip Prosthesis Component Due to Sterilant Concerns
FDA (Devices) · 2020-11-11

Same hazard · mechanical failure