The Recall Desk
HighFDA (Devices)·Z-2612-2021·Announced 2021-10-06

Corin Unity Knee Patella components recalled due to packaging damage

Corin is recalling Corin Unity Knee Patella components due to potential packaging damage that could compromise sterility and device integrity. Affected units were distributed in nine US 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: This is a surgical implant (risk-of-harm product) where packaging damage could result in loss of sterility or contamination. No illnesses or injuries have been reported. Per the severity rubric, risk-of-harm products where injury has not yet been reported receive a score of 3 (High).

Plain-English summary

Corin Ltd is recalling specific units of the Corin Unity Knee Patella, Size 3 (REF 112.018.06), a component of the Unity Total Knee System. The devices were recalled because the packaging system has potential for physical and water damage, which could result in device damage, loss of sterility, or contamination of the devices.

Affected units were distributed to healthcare facilities in Arizona, California, Florida, Illinois, Oklahoma, Pennsylvania, Texas, Utah, and Wisconsin. The affected products were delivered between July 22 and July 26, 2021, with Lot number 473755 delivered on July 26, 2021.

The recalled product

Product
Corin Unity Knee Patella, Size 3 / 8.5mm, Centered Dome 3 PEG-UHMWPE, REF 112.018.06, Sterile, a component of the Unity Total Knee System.
Manufacturer
Corin Ltd
Category
Medical Device — Orthopedic / Joint Implant
Hazard
  • physical-damage
  • water-damage
  • sterility-loss
  • contamination

Distribution

Distributed nationwide across the United States.

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