Corin recalls specific Unity Knee Patella components (size 3/8.5mm) delivered 7/22-26/2021 due to packaging risks causing contamination or loss of sterility. Affected units may require replacement.
The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the devices.
Corin is recalling certain Unity Knee Patella components (size 3/8.5mm) because their packaging could lead to contamination or loss of sterility. This affects patients who received these components during the specified delivery dates.
The packaging system could cause physical damage or water exposure, leading to loss of sterility or contamination of the components. This poses a risk during surgical procedures if the components are not properly sterilized.
Patients who received the recalled Unity Knee Patella components between July 22-26, 2021, are most at risk. The recall applies to specific shipment batches delivered during this period.
Check for the product name 'Corin Unity Knee Patella, Size 3 / 8.5mm, Centered Dome 3 PEG-UHMWPE, REF 112.018.06, Sterile' on the packaging. The affected units were delivered to patients between July 22-26, 2021, with lot number 473755 delivered on July 26, 2021.
Identify if your component matches the product name and delivery dates specified in the recall notice.
The packaging system could cause physical damage or water exposure, leading to loss of sterility or contamination of the components.
The affected products were delivered between July 22-26, 2021.
The recall notice does not specify a remedy, so contact Corin Ltd directly for guidance.
We’ve drafted a message you can send Corin to request your refund or repair — edit it as you like.
Subject: Recall Z-2612-2021 — Corin Corin Hello, I own a Corin that is covered by recall Z-2612-2021 from Corin. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.