ProPlan CMF Patient-Specific Guide recall
ProPlan CMF Patient-Specific Guide, Mandible guides (3A & 3B)-Intended to guide the marking of bone and/or guide surgical instruments in mandibular…
Why was ProPlan CMF Patient-Specific Guide recalled?
Wrong versions of guides 3A and 3B (Patient Specific) were shipped prior to the re-design request
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI: 05420060351013 Lot Case Number: MU23-JOQ-LID
- Product
- ProPlan CMF Patient-Specific Guide, Mandible guides (3A & 3B)-Intended to guide the marking of bone and/or guide surgical instruments in mandibular…
- Recalling firm
- Materialise N.V.
- Quantity
- 1 unit
- Distribution
- US Nationwide distribution in the state of KY.
- Recall date
- August 9, 2023
- Classification
- Class II
- Status
- Completed
- Agency
- FDA (device)