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 Initiated
- February 27, 2015
- Posted
- May 14, 2015
- Terminated
- October 13, 2016
- Recall Number
- Z-1614-2015
- Quantity
- 4 units
- Firm Location
- Mahwah, NJ
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.
Distribution
US Nationwide distribution in the states of MA and RI.
Lot / Code Info
Catalog No. 6476-8-260, Lot code: EJPLC
Root Cause
Mixed-up of materials/components
Action Taken
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.