Home / Recalls / Zimmer CAS / Z-0495-2015

Z-0495-2015 Class II Terminated

Recalled by Zimmer CAS — Montreal, N/A

Recall Details

Product Type: Devices
Report Date: December 10, 2014
Initiation Date: November 3, 2014
Termination Date: February 13, 2015
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 15

Product Description

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.

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.

Distribution Pattern

US Distribution in states of: AZ, CO, IL, OR, and WA.

Code Information

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