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Open, Classified

Apex Knee System. Model Numbers: KC-50090, KC-50097, KC-50110, KC-50117, KC-50130, KC-50135, KC-50137, KC-50150, KC-50155, KC-50157, KC-50170, KC-50175, KC-50177, KC-50190, KC-50197, KC-52104, KC-52554, KC-52574, KC-52774, KC-55223, KC-55243

FDA Recall Z-2069-2025 · Posted 2025-07-02

Recalling FirmCORIN MEDICAL, LTD.
Recall StatusOpen, Classified
Product CodeJWH
Date Initiated2025-05-23
Product Quantity341 units

Reason for Recall

Investigation has identified that the age of the nylon packaging material has caused a loss of integrity of some pouches.

Firm Action

Corin Group notified US agents informally via email on 05/23/2025 and informed them of an investigation and affected inventory to quarantine. A formal notification was sent to consignees on about 06/02/2025. Consignees were instructed to identify any affected units on hand and quarantine them, return them to Corin and notify all affected parties who handled the product. Consignees were also requested to complete and return the acknowledgement form. If product was further distributed, Corin requested contact information to contact those customers.

Root Cause

Nonconforming Material/Component

Distribution Pattern

US Nationwide distribution in the states of CA, CO, FL, IL, OK, TX, UT.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K112891APEX REVISION KNEE SYSTEMSOmni Life Science, Inc. · 2012-02-29K101994APEX KNEE MODULAR TIBIA SYSTEMOmnlife Science · 2010-09-28

Official Source

View FDA Recall →

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

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