ProPlan CMF Guide (Materialise) – Incorrect Guide Versions (2023)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Materialise N.V. Technologielaan 15 Heverlee Belgium
Lot Codes / Batch Numbers
UDI: 05420060351013 Lot Case Number: MU23-JOQ-LID
Products Sold
UDI: 05420060351013 Lot Case Number: MU23-JOQ-LID
Materialise N.V. Technologielaan 15 Heverlee Belgium is recalling ProPlan CMF Patient-Specific Guide, Mandible guides (3A & 3B)-Intended to guide the marking of bone due to Wrong versions of guides 3A and 3B (Patient Specific) were shipped prior to the re-design request. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Wrong versions of guides 3A and 3B (Patient Specific) were shipped prior to the re-design request
Recommended Action
Per FDA guidance
Synthes sales representative was made aware of the issue on 19 June 2023, by phone and email. Materialise requested the product to be returned on 19 June 2023, Synthes sales representative confirmed that surgery will be performed without guides and will return the case. The guides were returned/received at Materialise on 23 June 2023.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026