The Recall Desk
HighFDA (Devices)·Z-2611-2021·Announced 2021-10-06

Corin Unity Knee Implant Components Recalled for Packaging Damage Risk

Corin Ltd recalls two models of Unity Knee CS Insert implant components due to potential packaging damage that could compromise sterility or cause contamination. Affected devices were distributed in nine U.S. states in July 2021.

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 recall of sterile medical device components with no reported illnesses or injuries. The hazard is potential rather than confirmed—loss of sterility or device contamination could occur due to packaging defects. This scores as High (3) because sterility loss on implanted orthopedic devices constitutes a risk-of-harm product with serious potential consequences, even though no injuries have been reported yet.

Plain-English summary

Corin Ltd is recalling two models of Unity Knee CS Insert components from its total knee replacement system. The affected products are Size 5 with 9.0mm dimension (REF 1125182) and Size 8 with 10.0mm dimension (REF 1125243). These are sterile surgical implants used in total knee replacement procedures.

The recall was issued due to defects in the packaging system of the affected devices. These packaging defects present a risk of physical and water damage that could result in device damage, loss of sterility, or contamination. No infections, injuries, or illnesses have been reported in association with these products.

The affected devices were distributed to healthcare facilities in nine U.S. states: Arizona, California, Florida, Illinois, Oklahoma, Pennsylvania, Texas, Utah, and Wisconsin. Specifically, Lot 477942 (Model 1125182) was delivered on July 22, 2021, and Lot 479310 (Model 1125243) was delivered on July 23, 2021.

The recalled product

Product
Corin Unity Knee CS Insert, Size 5 / 9.0mm, Fixed Condylar Stabilised - UHMWPE, REF 1125182, Sterile, and Corin Unity Knee CS Insert, Size 8 / 10.0mm, Fixed Condylar Stabilised - UHMWPE, REF 1125243, Sterile, both are components of the Unity Total Knee System.
Manufacturer
Corin Ltd
Category
Medical Device — Orthopedic / Joint Implant
Hazard
  • sterility-loss
  • contamination

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)

  • model 1125243 - Lot number 479310 was delivered 7/23/2021.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category