Scorpio and Duracon Total Knee Systems
Brand(s)
Summary
Contact the manufacturer if you require additional information.
Affected products
Affected products |
Lot or serial number |
Model or catalog number |
|---|---|---|
Trident Acetabular Shell - Conventional Polyethylene |
38059601 |
620-00-28J |
Duracon Total Knee System - Revision Tibial Insert - Mod Rev/Dur Rev |
42771401 |
6637-0-928 |
Duracon Total Knee System - PCA Review - Tibial Insert |
33164901 |
6637-4-231 |
Scorpio NRG Knee System - Cruciate Retaining Tibial Insert |
42912101 |
82-2-0910 |
Scorpio Total Knee - Resurfacing Patellar Component |
More than 10 numbers, contact manufacturer. |
73-0510 |
Scorpio Total Knee - Universal Dome Patellar Component |
More than 10 numbers, contact manufacturer. |
73-3110 |
Scorpio Total Knee - Concentric Dome Patellar Component |
More than 10 numbers, contact manufacturer. |
73-2110 |
Issue
The industry guidance for storage duration of Ultra High Molecular Weight Polyethylene (UHMWPE) raw material used in the manufacture of soft implant bearing/articulating material of prosthetic joints is less than 5 years. Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. Stryker has become aware that the devices listed in the product/lot number attachment PFA 3306872 section of the customer letter have been manufactured with UHMWPE raw material aged over 5 years.
Recall Start Date: December 5, 2023
Additional information
Details
Howmedica Osteonics Corporation
325 Corporate Drive, Mahwah, New Jersey, United States, 07430
Get notified
Receive notifications for new and updated recalls and alerts by category.