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U.S. Department of Health and Human Services

Class 2 Device Recall Zimmer PSI Knee Persona" Jigs (Patient Specific Instrumentation)

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  Class 2 Device Recall Zimmer PSI Knee Persona" Jigs (Patient Specific Instrumentation) see related information
Date Initiated by Firm November 03, 2014
Date Posted December 16, 2014
Recall Status1 Terminated 3 on February 13, 2015
Recall Number Z-0495-2015
Recall Event ID 69630
510(K)Number K131409  
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
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.
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
Recalling Firm/
Manufacturer		 Zimmer CAS
75 Queen St #3300
Montreal Canada
For Additional Information Contact Jean-Sebastien M¿rette
514-861-4074 Ext. 292
Manufacturer 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.
FDA Determined
Cause 2		 Software design
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 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
Quantity in Commerce 15
Distribution US Distribution in states of: AZ, CO, IL, OR, and WA.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JWH and Original Applicant = ORTHOSOFT, INC.
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