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.
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.
What You Should Do
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 corporatequality.postmarket@zimmer.com; 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: jean-sebastien.merette@zimmercas.com
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Products
- Brand
- Zimmer CAS
- UPC
- 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
Units Affected
15