Agency classClass IIOur severity:High FDA (Devices)·Z-0450-2019·Announced 2018-11-21

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

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 involves a structural defect in a medical device used for fracture stabilization. While no injuries or illnesses are reported in the source text, the risk of harm from a device that cannot function as intended during surgery places this in the 'High' category per the rubric for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Zimmer Biomet, Inc. is recalling 2,163 units of the Affixus Hip Fracture Nail Left 125 Deg 9x165mm (Item Number 816709165). The recall covers specific lot numbers: 063610, 063630, and 816520. 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 fixation of the hip fracture.

The affected devices were distributed nationwide in the United States to 43 states and Puerto Rico, as well as to Chile, Costa Rica, Ecuador, and the Netherlands. Healthcare providers and facilities that have received these specific lot numbers should stop using them and contact Zimmer Biomet for instructions on return or replacement.

The recalled product

Product: Affixus Hip Fracture Nail Left 125 Deg 9x165mm, Item Number 816709165 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 Implants
Hazard: mechanical-failure
surgical-complication
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 063610 063630 816520

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 →

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FDA (Devices) · 2020-12-30
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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