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Completed

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

FDA Recall Z-2287-2023 · Posted 2023-08-03

Recalling FirmMaterialise N.V.
Recall StatusCompleted
Product CodeJEY
Date Initiated2023-06-19
Product Quantity1 unit

Reason for Recall

Wrong versions of guides 3A and 3B (Patient Specific) were shipped prior to the re-design request

Firm Action

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.

Root Cause

Process change control

Distribution Pattern

US Nationwide distribution in the state of KY.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K103136SURGICASE CMF, SURGICASE CONNECT, SURGICASE GUIDEMaterialise NV · 2011-03-18

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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