FDA Medical Device Recalls (openFDA)
Stryker Howmedica Osteonics Corp.: 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.
- Recall number
- Z-1614-2015
- Recalling firm
- Stryker 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.
- Status
- Terminated
- Initiated
- 2015-02-27
- Posted
- 2015-05-14
- Terminated
- 2016-10-13
- Reason
- 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
- 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: so_m_product_field_action_response@stryker.com or faxed to: 1-855-251-3635. For question call 201-831-6365.
- Quantity
- 4 units
- Distribution
- US Nationwide distribution in the states of MA and RI.
- Lot, serial or model codes
- Catalog No. 6476-8-260, Lot code: EJPLC
- 510(k) numbers
- ["K904208"]
- PMA numbers
- not on file
- Product code
- JWH
- Firm FEI
- 3003070421
- Firm city
- Mahwah
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28