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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 1
Distribution
Part of a larger recall action
This product is one of 10 recalled by Corin Ltd 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.
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