Z-1614-2015Class II

Kinemax Stem Extenders, 80 mm

Name: Z-1614-2015 Kinemax Stem Extenders, 80 mm
Creator: Stryker Howmedica Osteonics Corp.
Published: 2015-02-27
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2015-02-27 / Terminated / root cause: labeling and UDI

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Kinemax Stem Extenders, 80 mm, Product Usage: Kinemax Cemented Stem Extenders are modular components designed to be mated with tibial baseplates or femoral... on 2015-02-27. FDA classified it as Class II and gives the reason as "Stryker received four customer complaints reporting that inside the box labeled part #6476-8-260 (Kinemax Stem Extenders, 80 mm) there was a different part #6476-8-250 (Kinemax Stem Extenders, 40 mm". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1614-2015
Classification: Class II
Status: Terminated
Initiated: 2015-02-27
Posted: 2015-05-14
Terminated: 2016-10-13
Recalling firm: Howmedica Osteonics Corp
Product: Kinemax Stem Extenders, 80 mm, Product Usage: Kinemax Cemented Stem Extenders are modular components designed to be mated with tibial baseplates or femoral components of the Modular Rotating Hinge (MRH), Scorpio Total Stabilizer (TS) or Duracon TS knee replacement systems. The Kinemax Cemented Stem Extenders are available in three different lengths, 40 mm (Part #6476-8-250), 80mm (Part #6476-8-260) and 155mm (Part #6476-8-270). The 40 mm cemented stem extender is not indicated for use in the MRH system; however, it is indicated for use with the Scorpio TS and Duracon TS systems (LRKS/G Rev. 2). Both the 80mm and 155mm stem extenders are indicated for use in all three systems.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: Stryker received four customer complaints reporting that inside the box labeled part #6476-8-260 (Kinemax Stem Extenders, 80 mm) there was a different part #6476-8-250 (Kinemax Stem Extenders, 40 mm.
Root cause tag: labeling and UDI
FDA root cause: Mixed-up of materials/components
Action: Stryker Orthopaedics an Urgent Medical Device Recall Letter/Notification Acknowledgement Form dated April 9, 2015 to their affected customers. The recall letter identified the affected product, problem and actions to be taken. Customers are asked to contact their Stryker Orthopaedics Sales Representative to arrange for return of the product if they have any of the affected items. Customers are asked to complete and return the acknowledgement form within 5 days by emailing to: [email protected] or faxed to: 1-855-251-3635. For question call 201-831-6365.
Quantity in commerce: 4 units
Distribution: US Nationwide distribution in the states of MA and RI.
Product codes and lots: Catalog No. 6476-8-260, Lot code: EJPLC

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1614-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1614-2015	Class II	Terminated	Voluntary: Firm initiated	2015-05-20	2015-05-14

Product code JWH

K904208Class IIKinemax Superstabilizer Total Knee SystemHowmedica Corp. / cleared 1991-04-01

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)