Recall Z-2287-2023— Materialise N.V.

Name: FDA recall Z-2287-2023
Creator: U.S. Food and Drug Administration
Published: 2023-06-19

Class II · Completed

Class II FDA medical device recall by Materialise N.V., initiated 2023-06-19. It names one FDA 510(k) clearance: K103136. Product: 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: Wrong versions of guides 3A and 3B (Patient Specific) were shipped prior to the re-design request.

Recalling firm: Materialise N.V.
Classification: Class II
Status: Completed
Initiated: 2023-06-19
Firm location: Heverlee, N/A, Belgium

510(k) clearances named in this recall

1 on FDA's record

K103136 — SURGICASE CMF, SURGICASE CONNECT, SURGICASE GUIDEMaterialise NV·cleared 2011-03-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.