Z-2287-2023Class II

ProPlan CMF Patient-Specific Guide, Mandible guides (3A & 3B)-Intended to guide the marking of bone and/or...

Name: Z-2287-2023 ProPlan CMF Patient-Specific Guide, Mandible guides (3A & 3B)-Intended to guide the marking of bone and/or...
Creator: Materialise N.V.
Published: 2023-06-19
License: https://open.fda.gov/license/

Materialise N.V. / initiated 2023-06-19 / Completed / root cause: design

FDA source

Materialise N.V. began a recall of ProPlan CMF Patient-Specific Guide, Mandible guides (3A & 3B)-Intended to guide the marking of bone and/or guide surgical instruments in mandibular and... on 2023-06-19. FDA classified it as Class II and gives the reason as "Wrong versions of guides 3A and 3B (Patient Specific) were shipped prior to the re-design request". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as design.

Recall record

Recall number: Z-2287-2023
Classification: Class II
Status: Completed
Initiated: 2023-06-19
Posted: 2023-08-03
Recalling firm: Materialise N.V.
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
Product code: JEY Plate, Bone
Reason for recall: Wrong versions of guides 3A and 3B (Patient Specific) were shipped prior to the re-design request
Root cause tag: design
FDA root cause: Process change control
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.
Quantity in commerce: 1 unit
Distribution: US Nationwide distribution in the state of KY.
Product codes and lots: UDI: 05420060351013 Lot Case Number: MU23-JOQ-LID

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2287-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2287-2023	Class II	Completed	Voluntary: Firm initiated	2023-08-09	2023-08-03

Product code JEY

K103136Class IISurgicase Cmf, Surgicase Connect, Surgicase GuideMaterialise NV / cleared 2011-03-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)