Z-2612-2021Class II

Corin Unity Knee Patella, Size 3 / 8.5mm, Centered Dome 3 PEG-UHMWPE, REF 112.018.06, Sterile, a component of...

Name: Z-2612-2021 Corin Unity Knee Patella, Size 3 / 8.5mm, Centered Dome 3 PEG-UHMWPE, REF 112.018.06, Sterile, a component of...
Creator: Corin Ltd
Published: 2021-07-28
License: https://open.fda.gov/license/

Corin Limited / initiated 2021-07-28 / Terminated / root cause: packaging

FDA source

Corin Ltd began a recall of 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 on 2021-07-28. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2612-2021
Classification: Class II
Status: Terminated
Initiated: 2021-07-28
Posted: 2021-09-30
Terminated: 2024-06-12
Recalling firm: Corin Limited
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.
Product code: MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
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.
Root cause tag: packaging
FDA root cause: Storage
Action: On 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 commerce: 1 unit
Distribution: US Nationwide distribution in the states of AZ, CA, FL, IL, OK, PA, TX, UT, and WI.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2612-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2603-2021	Class II	Terminated	Voluntary: Firm initiated	2021-10-06	2021-09-30
Z-2604-2021	Class II	Terminated	Voluntary: Firm initiated	2021-10-06	2021-09-30
Z-2605-2021	Class II	Terminated	Voluntary: Firm initiated	2021-10-06	2021-09-30
Z-2606-2021	Class II	Terminated	Voluntary: Firm initiated	2021-10-06	2021-09-30
Z-2607-2021	Class II	Terminated	Voluntary: Firm initiated	2021-10-06	2021-09-30
Z-2608-2021	Class II	Terminated	Voluntary: Firm initiated	2021-10-06	2021-09-30
Z-2609-2021	Class II	Terminated	Voluntary: Firm initiated	2021-10-06	2021-09-30
Z-2610-2021	Class II	Terminated	Voluntary: Firm initiated	2021-10-06	2021-09-30
Z-2611-2021	Class II	Terminated	Voluntary: Firm initiated	2021-10-06	2021-09-30
Z-2612-2021	Class II	Terminated	Voluntary: Firm initiated	2021-10-06	2021-09-30

Product code MEH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)