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U.S. Department of Health and Human Services

Class 2 Device Recall Unity Total Knee System

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 Class 2 Device Recall Unity Total Knee Systemsee related information
Date Initiated by FirmJuly 28, 2021
Create DateSeptember 30, 2021
Recall Status1 Terminated 3 on June 12, 2024
Recall NumberZ-2612-2021
Recall Event ID 88589
Product Classification Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate - Product Code MEH
ProductCorin 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.
Code Information The affected products are shipment specific and were delivered to the consignee between 7/22-26/2021. Lot number 473755 was delivered 7/26/2021.
Recalling Firm/
Manufacturer		 Corin Ltd
Unit 1-57-8
Corinium Centre
Cirencester United Kingdom
For Additional Information ContactMs. Marie-Anne Euzen
441285659866
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Storage
ActionOn 7/28&29/2021, the firm sent emails entitled "IMPORTANT-containment request FA COUK 2021 013" which notified the consignee they have been identified as receiving one or more of the medical devices listed in the attached Excel file due to them potentially having physical and/or water damage. They were to quarantine the parts until further instructions were issued. On 9/7/2021, Corin USA issued recall letters dated 9/3/2021 via email on 9/7/2021 requesting the devices be quarantined and returned.
Quantity in Commerce1 unit
DistributionUS Nationwide distribution in the states of AZ, CA, FL, IL, OK, PA, TX, UT, and WI.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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