Kinemax Stem Extenders, 80 mm recallZ-1614-2015 · Stryker Howmedica Osteonics Corp. · initiated Feb 27, 2015
Class II Terminated All recalls posted in May 2015
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Stryker Howmedica Osteonics Corp. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Mixed-up of materials/components
What the company is doing
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.
Recall details
- Recall number
- Z-1614-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Feb 27, 2015
- Posted by the FDA
- May 14, 2015
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Quantity
- 4 units
- Product code
- JWH
- FDA submissions
- K904208
- Distribution
- US Nationwide distribution in the states of MA and RI.
Product description
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.
Code information (models, lots, serial numbers)
Catalog No. 6476-8-260, Lot code: EJPLC
Other devices under the same FDA submission
2 devices cleared under K904208 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Kinemax 6476-8-260Howmedica Osteonics Corp. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER5 reports
- Kinemax 6476-8-270Howmedica Osteonics Corp. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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