Materialise N.V. 2023-08-09 Health serious FDA
Health · FDA · Recall #FDA-Z-2287-2023
ProPlan CMF Patient-Specific Guide, Mandible guides (3A & 3B)-Intended to guide the… Recall
Issued August 9, 2023 · Materialise N.V.
In August 2023, Materialise N.V. recalled the ProPlan CMF Patient-Specific Guide, Mandible guides (3A & 3B)-Intended to guide the…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Wrong versions of guides 3A and 3B (Patient Specific) were shipped prior to the re-design request
What you should do
- 1 Stop using ProPlan CMF Patient-Specific Guide, Mandible guides (3A & 3B)-Intended to guide the… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Materialise N.V. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Materialise N.V.
- Category
- Health
- Recall date
- August 9, 2023
- Units affected
- Not reported
- Sold at
- US Nationwide distribution in the state of KY.
- Recall number
- FDA-Z-2287-2023
- Made in
- Belgium
- Issuing agency
- FDA
In context
- Materialise N.V. has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 903rd Health recall we've logged in 2023.