OMNIlife science Inc.: Medical Device Recall in 2018 - (Recall #: Z-1117-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Apex Knee System, Tibial Baseplate Size 6 Left, non-porous - KC-2206L The Apex Knee System is intended for use as a primary or revision total knee replacement. This knee replacement system is intended for cemented fixation and single use implantation. This prosthesis may be used for the following conditions, as appropriate: Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis; Rheumatoid arthritis; Correction of functional deformity; Revision procedures where other treatments or devices have failed.

Product Classification:

Class II

Date Initiated: November 20, 2017

Date Posted: March 28, 2018

Recall Number: Z-1117-2018

Event ID: 79268

Reason for Recall:

The Apex Knee System Tibial Baseplate identified has an improper expiration date marked on the external packaging. The improper expiration date (2202-03) is marked on the external packaging only. The correct lot number (2022-03) is present in the internal packaging and sterile batch documentation.

Status: Terminated

Product Quantity: 32

Code Information:

Product Code KC-2206L, Lot # 26519

Distribution Pattern:

Worldwide Distribution - US Distribution and to the country Spain.

Voluntary or Mandated:

Voluntary: Firm initiated