ProPlan CMF recallZ-2287-2023 · Materialise N.V. · initiated Jun 19, 2023
Completed
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Materialise N.V. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Wrong versions of guides 3A and 3B (Patient Specific) were shipped prior to the re-design request
FDA root cause category: Process change control
What the company is doing
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.
Recall details
- Recall number
- Z-2287-2023
- Status
- Completed
- Initiated by the company
- Jun 19, 2023
- Posted by the FDA
- Aug 3, 2023
- Recalling firm
- Materialise N.V.
- Quantity
- 1 unit
- Product code
- JEY
- FDA submissions
- K103136
- Distribution
- US Nationwide distribution in the state of KY.
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
Code information (models, lots, serial numbers)
UDI: 05420060351013 Lot Case Number: MU23-JOQ-LID
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- ProPlan CMF SD900.101Materialise NV · Plate, Bone1 recall1 report
Product lines
Other devices under the same FDA submission
5 devices cleared under K103136 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- ProPlan CMF SD900.001Materialise NV · Plate, Bone2 reports
- ProPlan CMF SD900.008Materialise NV · Plate, Bone1 report
- ProPlan CMF SD900.051Materialise NV · Plate, Bone1 report
- ProPlan CMF SD900.102Materialise NV · Plate, Bone1 report
- ProPlan CMF SD900.111Materialise NV · Plate, Bone1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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