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Terminated

Omnilife Science Apex Knee System Modular Tibia Augment, Size 2 x 4mm Ref: KC-54020. The Apex Knee System is intended for use as a primary or revision total knee replacement.

FDA Recall Z-2371-2012 · Posted 2012-09-13

Recalling FirmOmni Life Science
Recall StatusTerminated
Product CodeJWH
Date Initiated2012-08-09
Date Terminated2013-01-10
Product Quantity286 units

Reason for Recall

The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compromising the sterility

Firm Action

Omnilife Science contacted affected customers by phone and sent an "URGENT MEDICAL DEVICE RECALL" e-mail on August 9, 2012. The e-mail identifies the product, problem, and actions to be taken by the customers. Customers with questions regarding product return should contact Customer Service at 800-448-6664. Customers with questions regarding the recall should contact the firm at 774-226-1845.

Root Cause

Packaging

Distribution Pattern

Worldwide Distribution-USA (nationwide including the states of CO, NY, OK, PA, UT, VA, and WI, and the countries of Spain and the Netherlands.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K094017TIBIAL BASEPLATE AUGMENT MODEL KC-22118, KC-22128, KC-22138, KC-22148, KC-22158Omni Life Science, Inc. · 2010-03-05

Official Source

View FDA Recall →

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

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