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.
FDA Recall Z-0495-2015 · Posted 2014-12-16
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Recalling FirmZimmer CAS
Recall StatusTerminated
Product CodeJWH
Date Initiated2014-11-03
Date Terminated2015-02-13
Product Quantity15
Reason for Recall
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.
Firm Action
The firm, Zimmer CAS, sent an "URGENT: MEDICAL DEVICE NOTIFICATION" dated November 3, 2014 to its customers. The notice described the product, problem and actions to be taken. The customers were instructed to read this notice and be familiar with its contents; complete and return the attachment 1 CERTIFICATE OF ACKNOWLEDGEMENT form via fax to Zimmer Inc. at (574) 372-4265 or scan and email to [email protected]; and maintain a copy of the completed attachment 1 for your files.
If you have questions concerning this notice, please call 514-861-4074 ext 292 or email: [email protected]
Root Cause
Software design
Distribution Pattern
US Distribution in states of: AZ, CO, IL, OR, and WA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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