FDA-Device2014-12-10Class II
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.
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.
Sold states
US Distribution in states of: AZ, CO, IL, OR, and WA.
Affected count
15
Manufactured in
75 Queen St #3300, N/A, Montreal, N/A, Canada
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0495-2015Don't want to check this manually?
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