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Terminated

Unity Total Knee System. Used for knee prosthesis in total knee replacement

FDA Recall Z-0273-2023 · Posted 2022-11-21

Recalling FirmCorin Ltd
Recall StatusTerminated
Product CodeJWH
Date Initiated2022-10-31
Date Terminated2024-01-12
Product Quantity4 devices

Reason for Recall

The internal packaging system for devices may have damage to the blisters potentially damaging the device or compromising the sterility of the packaging.

Firm Action

Corin Group notified consignees on 10/31/2022 via letter titled "URGENT MEDICAL DEVICE RECALL." The letter instructed consignees to examine inventory, quarantine affected product, arrange for its return, and notify all facilities/personnel if devices were further distributed. Consignees were also asked to complete and return the acknowledgement form by e-mail to [email protected]. For all questions on this notice, please contact me at +1 772-321-2478 or by e-mail to [email protected].

Root Cause

Under Investigation by firm

Distribution Pattern

Distribution in the US to New Jersy and Puerto Rico. International distribution to South Africa and France.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K113060UNITY TOATAL KNEE SYSTEMCorin USA · 2012-09-10

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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