The Recall Desk
HighFDA (Devices)·Z-0273-2023·Announced 2022-11-30

Knee Prosthesis Devices Recalled for Potential Sterility Packaging Issue

Corin Ltd is recalling the Unity Total Knee System due to potential damage to internal packaging that could compromise device sterility. No injuries have been reported.

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: FDA Class II device with potential sterility packaging compromise affecting a surgical implant, with no reported injuries or illnesses. Meets the High rubric criterion: risk-of-harm product where injury has not yet been reported.

Plain-English summary

Corin Ltd is recalling the Unity Total Knee System, a knee prosthesis used in total knee replacement surgery. The recall affects 4 devices with Model Number 112.040.06 and Lot Number 504337.

The internal packaging system for these devices may have damage to the protective blisters. This potential damage could affect the device itself or compromise the sterility of the packaging.

The affected devices were distributed in the United States to New Jersey and Puerto Rico. Additional distribution occurred internationally to South Africa and France. No illnesses or injuries related to this issue have been reported.

The recalled product

Product
Unity Total Knee System. Used for knee prosthesis in total knee replacement
Manufacturer
Corin Ltd
Category
Medical Device
Hazard
  • blister-damage
  • sterility-compromise

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 (2)

  • Model Number: 112.040.06
  • Lot Number: 504337

Distribution

Distribution scope not specified by the agency.

Related recalls

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