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
Reported: August 9, 2023 Initiated: June 19, 2023 #Z-2287-2023
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
Reason for Recall
Wrong versions of guides 3A and 3B (Patient Specific) were shipped prior to the re-design request
Details
- Recalling Firm
- Materialise N.V.
- Units Affected
- 1 unit
- Distribution
- US Nationwide distribution in the state of KY.
- Location
- Heverlee, N/A
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Materialise N.V.. Units affected: 1 unit.
Why was this product recalled? ▼
Wrong versions of guides 3A and 3B (Patient Specific) were shipped prior to the re-design request
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 9, 2023. Severity: Moderate. Recall number: Z-2287-2023.
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