Agency classClass IIOur severity:High FDA (Devices)·Z-3141-2018·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 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, and the defect involves a structural component of a medical implant where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Zimmer Biomet, Inc. is recalling 5,947 units of the Affixus Hip Fracture Nail Right 130° 13 mm x 460 mm (Item Number: 814513460). 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 affected include AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, and WY.

Healthcare providers and facilities should contact Zimmer Biomet for instructions on how to return the affected devices. This recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product: Affixus¿ Hip Fracture Nail Right 130¿ 13 mm x 460 mm, Item Number: 814513460
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)

558790 711090 901520

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.

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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
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Same hazard · mechanical failure