The Recall Desk
HighFDA (Devices)·Z-2610-2021·Announced 2021-10-06

Corin Unity Knee Augments Recalled Due to Packaging Damage and Sterility Loss

Corin Ltd is recalling Corin Unity knee implant augments because packaging damage could compromise device sterility and allow contamination. Affected units were distributed in 9 states during 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 an FDA Class II recall of a surgical implant with potential loss of sterility and contamination due to packaging damage. While no illnesses or injuries have been reported, the device qualifies as a risk-of-harm product where compromised sterility could lead to serious post-operative infection.

Plain-English summary

Corin Ltd is recalling Corin Unity Knee Augments, specifically Size 5, 6, and 7 femoral posterior augments (10mm thick, REF 1122370), which are components of the Unity Total Knee System used in knee replacement surgery.

The recall is due to damage to the packaging system that could result in physical damage to the devices, loss of sterility, or contamination. These issues could compromise the safety and effectiveness of the implant.

The affected products were distributed nationwide to healthcare facilities in Arizona, California, Florida, Illinois, Oklahoma, Pennsylvania, Texas, Utah, and Wisconsin. Specific units from shipments delivered between July 22-26, 2021, are affected, including lot number 472687 delivered on July 23, 2021.

Healthcare providers who received these devices should stop using affected units and contact Corin Ltd for replacement. Patients who received implants from these lots should consult their surgeon with any concerns.

The recalled product

Product
Corin Unity Knee Augments, Size 5, 6 & 7 / 10mm Thick, Femoral Posterior Augment, REF 1122370, Sterile, a component of the Unity Total Knee System.
Manufacturer
Corin Ltd
Category
Medical Device — Orthopedic Implant
Hazard
  • sterility-loss
  • contamination
  • device-damage

Distribution

Distributed nationwide across the United States.

Related recalls

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