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Open, Classified

Unity CR Femur Right, Size 6, Model Number 112.001.32 Primary and revision total knee arthroplasty

FDA Recall Z-0213-2024 · Posted 2023-11-02

Recalling FirmCorin Ltd
Recall StatusOpen, Classified
Product CodeJWH
Date Initiated2023-10-13
Product Quantity3 units

Reason for Recall

Potential for Unity CR Inserts Right size 6 from batch 529803 to be incorrectly labelled as Unity CR Inserts Right size 7 from batch 532405 and visa versa.

Firm Action

Corin issued a FIELD SAFETY NOTICE/RECALL LETTER to its consignees on 10/13/2023 via email. The notice explained the problem, potential risk if used, and requested the return of unused units. Distributors were directed to communicate the notice to applicable hospitals.

Root Cause

Process change control

Distribution Pattern

US: MI, TX, IL

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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