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U.S. Department of Health and Human Services

Class 2 Device Recall MRI Biomet Pin Guide for Total Knee Arthroplasty

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  Class 2 Device Recall MRI Biomet Pin Guide for Total Knee Arthroplasty see related information
Date Initiated by Firm April 26, 2023
Date Posted July 20, 2023
Recall Status1 Completed
Recall Number Z-2213-2023
Recall Event ID 92621
510(K)Number K173445  K221337  
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Product MRI Biomet Pin Guide for Total Knee Arthroplasty (Zimmer Biomet Patient Specific Instruments (PSI)-- patient-matched device designed to fit the patients anatomy to transfer a patient-specific pre-operative plan to the OR.
Ref: KNM-ZB02-00-01
Code Information UDI-DI: (01)05420060310027 Lot Number/Case Number: ZB22UHINEF, ZB23MANOLA
Recalling Firm/
Manufacturer		 Materialise N.V.
Technologielaan 15
Heverlee Belgium
For Additional Information Contact SAME
3216396611
Manufacturer Reason
for Recall		 The wrong tibia guide was included intended for a different patient case.
FDA Determined
Cause 2		 Process control
Action Materialise notified Zimmer Biomet international logistics on April 26, 2023 via email and telephone requested return of cases. Zimmer BIomet confirmed that they would directly contact the customer to return the original cases ZB23-MAN-OLA and ZB22-UHI-NEF. Materialise shipped replacement cases on May 2, 2023 and May 3, 2023. For questions call +1-734-259-7010 or email: zimmerbiomet@materialise.com.
Quantity in Commerce 2 Guides
Distribution International Distribution to countries of: Germany, Netherlands
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.
510(K) Database 510(K)s with Product Code = JWH and Original Applicant = Materialise NV
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