Zimmer CAS 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. Recall
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Zimmer CAS
Lot Codes / Batch Numbers
BKL0398L 20-8070-002-01, DHA0645L 20-8070-002-01, DHA0646R 20-8070-002-02, ECO0516L 20-8070-002-01, GHE0651R 20-8070-002-02, KAD0595L 20-8070-002-01, KWI0523R 20-8070-002-02, MHA0483L 20-8070-002-01, MHA0484R 20-8070-002-02, MKE0659R 20-8070-002-02, MMA0728R 20-8070-002-02, SSC0782L 20-8070-001-01, TCA0582L 20-8070-002-01, THO0803L 20-8070-002-01, TMA0760L 20-8070-002-01, Expiration dates 5/8/14-12/31/15
Products Sold
BKL0398L 20-8070-002-01; DHA0645L 20-8070-002-01; DHA0646R 20-8070-002-02; ECO0516L 20-8070-002-01; GHE0651R 20-8070-002-02; KAD0595L 20-8070-002-01; KWI0523R 20-8070-002-02; MHA0483L 20-8070-002-01; MHA0484R 20-8070-002-02; MKE0659R 20-8070-002-02; MMA0728R 20-8070-002-02; SSC0782L 20-8070-001-01; TCA0582L 20-8070-002-01; THO0803L 20-8070-002-01; TMA0760L 20-8070-002-01; Expiration dates 5/8/14-12/31/15
Zimmer CAS is recalling PSI Knee System- Prosthesis, knee patellofemorotibial, semi-constrained, cemented, polymer/meal/poly due to Internal discovery found that the MRI scans in some PSI knee guides involved an additional rotation adjustments that could potentially lead to misalig. This is a Class I recall, indicating a high risk of serious health consequences or death. Based on FDA medical device enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, CO, IL, IN, OR, WA
Page updated: Jan 13, 2026