The Recall Desk
HighFDA (Devices)·Z-0834-2019·Announced 2019-02-20

Signature Orthopedics Recalls Three Genius Knee Cemented CR Femoral Components

Signature Orthopedics is voluntarily recalling three Genius Knee Cemented CR Femoral Components due to a product mix-up. The devices were distributed in Florida, New York, and Tennessee.

What this means for you

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, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The rubric assigns a score of 3 to risk-of-harm products where injury has not yet been reported, as no specific injuries are mentioned in the source text.

Plain-English summary

Signature Orthopedics Pty Limited is voluntarily recalling three units of the Genius Knee Cemented CR Femoral Component. The recall was initiated on December 10, 2018, and was classified as Class II by the FDA. The reason for the recall is a product mix-up.

The affected devices are identified by UDI # 09348215020330, Device Model # 121-07-3000, and Lot # 788F7-1. These knee replacement components were distributed in the United States, specifically in the states of Florida, New York, and Tennessee.

The recall status is currently terminated. The FDA Center for Devices and Radiological Health (CDRH) classified the recall on February 14, 2019, and the termination date is listed as December 14, 2020. The firm notified initial recipients via email.

The recalled product

Product
Genius Knee Cemented CR Femoral Component Product Usage: Knee replacement component
Manufacturer
Signature Orthopedics Pty Limited
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
3

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)

  • UDI # 09348215020330 Device Model # 121-07-3000 Lot # 788F7-1

Distribution

Distributed nationwide across the United States.

The notice also names 3 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Signature Orthopedics Pty Limited 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 2 products in this recall →

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