Agency classClass IIOur severity:High FDA (Devices)·Z-0447-2019·Announced 2018-11-21

Zimmer Biomet Recalls Affixus Hip Fracture Nails 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 mechanical failure in a medical device used for fracture stabilization, which poses a risk of harm, but the source text does not report any specific injuries or illnesses.

Plain-English summary

Zimmer Biomet, Inc. is recalling 2,163 units of the Affixus Hip Fracture Nail Left Deg 9x300mm (Item Number 814609300). The recall is due to a defect where the set screw is unable to advance or reverse from the original position in the nail.

The affected product is Lot number 371540. The Affixus Hip Fracture Nail System is an intramedullary hip screw used by surgeons to stabilize fractures of the proximal femur. The recall covers distribution in the United States (nationwide to specific states and Puerto Rico) and foreign countries including Chile, Costa Rica, Ecuador, and the Netherlands.

Consumers and healthcare providers should contact Zimmer Biomet for instructions on how to handle the affected devices. The source text does not specify a specific action for end-users other than the recall itself.

The recalled product

Product: Affixus Hip Fracture Nail Left Deg 9x300mm, Item Number 814609300 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 371540

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.

See all →

High
Zimmer Biomet Recalls Spinal Rod Cutters Due to Fracture Risk
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 · mechanical failure