Z-1117-2018Class II

Apex Knee System, Tibial Baseplate Size 6 Left, non-porous - KC-2206L The Apex Knee System is intended for...

Name: Z-1117-2018 Apex Knee System, Tibial Baseplate Size 6 Left, non-porous - KC-2206L The Apex Knee System is intended for...
Creator: OMNIlife science Inc.
Published: 2017-11-20
License: https://open.fda.gov/license/

Omni Life Science, Inc. / initiated 2017-11-20 / Terminated / root cause: packaging

FDA source

OMNIlife science Inc. began a recall of 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... on 2017-11-20. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1117-2018
Classification: Class II
Status: Terminated
Initiated: 2017-11-20
Posted: 2018-03-19
Terminated: 2019-06-07
Recalling firm: Omni Life Science, Inc.
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.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
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.
Root cause tag: packaging
FDA root cause: Incorrect or no expiration date
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.
Quantity in commerce: 32
Distribution: Worldwide Distribution - US Distribution and to the country Spain.
Product codes and lots: Product Code KC-2206L, Lot # 26519

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1117-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1117-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-28	2018-03-19

Product code JWH

K060192Class IIApex Knee SystemOmni Life Science, Inc. / cleared 2006-06-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)