Recall Z-1117-2018— OMNIlife science Inc.

Name: FDA recall Z-1117-2018
Creator: U.S. Food and Drug Administration
Published: 2017-11-20

Class II · Terminated

Class II FDA medical device recall by OMNIlife science Inc., initiated 2017-11-20, terminated 2019-06-07. It names one FDA 510(k) clearance: K060192. Product: 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.. Reason: 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..

Recalling firm: OMNIlife science Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-11-20
Terminated: 2019-06-07
Firm location: Raynham, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K060192 — APEX KNEE SYSTEMOmni Life Science, Inc.·cleared 2006-06-15

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.