Reported Aug 9, 2023 · Completed
ProPlan CMF Patient-Specific Guide, Mandible guides (3A & 3B)-Intended to guide the marking of bone and/or guide…
Materialise N.V.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Materialise N.V. · Technologielaan 15 · Heverlee, N/A · N/A
Is this the product you have?
- 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 numberSD900.101
- Lot codes and dates
- UDI05420060351013
- Lot Case NumberMU23-JOQ-LID
- Amount recalled
- 1 unit
Where it was sold
- Nationwide
- KY
Why it was recalled
Wrong versions of guides 3A and 3B (Patient Specific) were shipped prior to the re-design request
This product could cause temporary or reversible health problems — stop using it.
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