The Recall Desk
ModerateFDA (Devices)·Z-0833-2019·Announced 2019-02-20

Signature Orthopedics Recalls Genius Knee Cemented Tibial Components Due to Product Mix-Up

Signature Orthopedics is recalling 10 Genius Knee Cemented Tibial Components due to a product mix-up. The recall covers units distributed in Florida, New York, and Tennessee.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II and is a voluntary, firm-initiated action for a product mix-up. There are no reported injuries, illnesses, or deaths in the source text, and the hazard is administrative rather than a high-risk pathogen or structural defect.

Plain-English summary

Signature Orthopedics Pty Limited is voluntarily recalling 10 units of the Genius Knee Cemented Tibial Component. This knee replacement component was distributed in the United States, specifically in the states of Florida, New York, and Tennessee. The recall was initiated because of a product mix-up.

The affected devices are identified by UDI # 09348215020309, Device Model # 121-07-4004, and Lot # 77A3F. The recall was initiated on December 10, 2018, and was classified as Class II by the FDA. The recall status is currently terminated, with a termination date of December 14, 2020.

Healthcare providers and patients who have received or used these specific components should contact Signature Orthopedics Pty Limited for further instructions on how to proceed with the recall.

The recalled product

Product
Genius Knee Cemented Tibial Component Product Usage: Knee replacement component
Manufacturer
Signature Orthopedics Pty Limited
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
10

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 # 09348215020309 Device Model # 121-07-4004 Lot # 77A3F

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 →

Related recalls

Same manufacturer · Signature Orthopedics Pty Limited

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