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U.S. Department of Health and Human Services

Class 2 Device Recall ProPlan CMF PatientSpecific Guide, Mandible guides

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  Class 2 Device Recall ProPlan CMF PatientSpecific Guide, Mandible guides see related information
Date Initiated by Firm June 19, 2023
Date Posted August 03, 2023
Recall Status1 Completed
Recall Number Z-2287-2023
Recall Event ID 92732
510(K)Number K103136  
Product Classification Plate, bone - Product Code JEY
Product ProPlan CMF Patient-Specific Guide, Mandible guides (3A & 3B)-Intended to guide the marking of bone and/or guide surgical instruments in mandibular and maxillofacial surgical procedures.
Identification number: SD900.101
Code Information UDI: 05420060351013 Lot Case Number: MU23-JOQ-LID
Recalling Firm/
Manufacturer		 Materialise N.V.
Technologielaan 15
Heverlee Belgium
For Additional Information Contact SAME
3216396611
Manufacturer Reason
for Recall		 Wrong versions of guides 3A and 3B (Patient Specific) were shipped prior to the re-design request
FDA Determined
Cause 2		 Process change control
Action Synthes sales representative was made aware of the issue on 19 June 2023, by phone and email. Materialise requested the product to be returned on 19 June 2023, Synthes sales representative confirmed that surgery will be performed without guides and will return the case. The guides were returned/received at Materialise on 23 June 2023.
Quantity in Commerce 1 unit
Distribution US Nationwide distribution in the state of KY.
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 = JEY and Original Applicant = MATERIALISE N.V.
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