Agency classClass IIOur severity:Severe FDA (Devices)·Z-3097-2018·Announced 2018-09-19

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

Zimmer Biomet is recalling 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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect in a load-bearing orthopedic implant, which meets the rubric criteria for a Severe rating.

Plain-English summary

Zimmer Biomet, Inc. is recalling 5,947 units of the Affixus Hip Fracture Nail Left 125° 11 mm x 460 mm (Item Number: 814411460). The recall was initiated because the set screw is not able to advance or reverse from the original position in the nail.

The affected products were distributed to 38 US states and Puerto Rico, as well as to Chile, Ecuador, Japan, and the Netherlands. The specific states involved include Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, and Wyoming.

Patients who have received this implant should contact their healthcare provider for evaluation. The recall is classified as Class II by the FDA.

The recalled product

Product: Affixus¿ Hip Fracture Nail Left 125¿ 11 mm x 460 mm, Item Number: 814411460
Manufacturer: Zimmer Biomet, Inc.
Category: Medical Device — Orthopedic Implant
Hazard: mechanical-failure
Affected units: 5,947

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)

054000 097060 285050 287410

Distribution

Distributed in 42 states:

Part of a larger recall action

This product is one of 129 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 129 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