ProPlan CMF Patient-Specific Guide, Mandible guides (3A & 3B)-Intended to guide the marking of bone and/or guide surgica
Summary
The FDA issued a Class II for ProPlan CMF Patient-Specific Guide, Mandible guides (3A & 3B)-Intended to guide by Materialise N.V.. Reason: Wrong versions of guides 3A and 3B (Patient Specific) were shipped prior to the re-design request.
Details
Source
Device Recall
External ID
Z-2287-2023
Action Date
2023-08-09
Status
Completed
Category
device
Product Description
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
Lot/Code Info: UDI: 05420060351013 Lot Case Number: MU23-JOQ-LID
Quantity Affected: 1 unit
Reason for Recall
Wrong versions of guides 3A and 3B (Patient Specific) were shipped prior to the re-design request
Distribution
US Nationwide distribution in the state of KY.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-06-19
Company
Heverlee, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 202 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Materialise N.V. has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Materialise N.V.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Materialise N.V. have FDA actions?
Materialise N.V. has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2287-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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