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.
FDA Recall Z-1117-2018 · Posted None
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Recalling FirmOMNIlife science Inc.
Recall StatusTerminated
Product CodeJWH
Date Initiated2017-11-20
Date Terminated2019-06-07
Product Quantity32
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.
Firm Action
OMNIlife science, Inc. sent an Urgent Medical Device Advisory Notice dated November 20, 2017.
Actions to be taken by the Customer/User
"Immediately quarantine lot 26519 for KC-2206L
"Return Product Using RMA# XXXX to OMNI.
"This advisory notice only includes LOT 26519. It does not affect other lots.
You must acknowledge this notice by returning the attached Acknowledgement and Receipt Form and accompanying by FAX to 508-819-3390 or my email to [email protected]. For further questions, please call (508) 824-2444.
Root Cause
Incorrect or no expiration date
Distribution Pattern
Worldwide Distribution - US Distribution and to the country Spain.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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