Home / Recalls / Medical Devices
Zimmer CAS recalls PSI Knee System- Prosthesis, knee patellofemorotibial, semi-constrained, cemented, polymer/meal/polymer The Zimmer PS
Recalled December 10, 2014 · FDA recall Z-0495-2015 · Zimmer CAS
Hazard
Internal discovery found that the MRI scans in some PSI knee guides involved an additional rotation adjustments that could potentially lead to misalignment due to a design flaw. · FDA Class II
Units
15
Sold at
US Distribution in states of: AZ, CO, IL, OR, and WA.
Description
Internal discovery found that the MRI scans in some PSI knee guides involved an additional rotation adjustments that could potentially lead to misalignment due to a design flaw.
Product
PSI Knee System- Prosthesis, knee patellofemorotibial, semi-constrained, cemented, polymer/meal/polymer The Zimmer PSI Knee System is indicated as an orthopedic instrument system to assist in the positioning of knee replacement components.
Manufacturer(s)
Zimmer CAS
Made in
Canada
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →