FDA Device

ProPlan CMF Anatomical Model, Maxilla-Cranium, Clear Identification number SD900.208

Hazard

MU22-INA-DUQ case was labeled as MU22-INA-DUQ but was shipped with the Anatomical Model of case MU22-NOF-SAK

What You Should Do

Remedy

Materialise USA LLC notified field representative via telephone on 13 July 2022 requesting the case to be returned. A replacement case was sent on 14 July 2022. Materialise picked up/received MU22-INQ-DUQ case with anatomical model MU22-NOF-SAK on 22 July 2022. This recall can be terminated as all distributed product (one case) has been returned to Materialise. No additional product remains in the field.

Affected by this recall?

Get a free legal consultation about this recall.

Talk to a Lawyer →

Affiliate link

Products

ProPlan CMF Anatomical Model, Maxilla-Cranium, Clear Identification number SD900.208
Brand
Materialise USA LLC
UPC
Unique Device Identifier (01)05420060352089(10)MU22INADUQ Lot Number: MU22-INQ-DUQ

Units Affected

1 unit

Related Recalls

FDA DEVICE

DePuy Synthes SYNMESH 10MM DIA 18MM HEIGHT (TI) Product Number: 495.344 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration that is best suited to the patient s individual pathology and anatomy. The mesh may also be trimmed for a custom fit. The implants can be inserted anteriorly, laterally or anterolaterally.

 FDA DEVICE

Normand Remisol Advance Data Manager is a software device that interfaces between laboratory information systems (LIS) and laboratory instruments.

 FDA DEVICE

Holder HKHZ 19 for use with Quadrox-i and Quadrox-iD Neonatal / Pediatric Oxygenators, Model Number: 701047495 - Product Usage: The Holder HKHZ 19 is an accessory to QUADROX i and QUADROX iD Neonatal / Pediatric oxygenator and is being used as a single holder for QUADROX i and QUADROX iD Neonatal / Pediatric Oxygenator and can also be used in combination with the holder's arm (016061) to use in cardiopulmonary bypass procedures (CPB) in a pediatric patient population.

 FDA DEVICE

LeverEdge Contrast Injector: 35 cc syringe with ISO 594 female luer lock - Product Usage: intended to be used to perfuse contrast medias into the vessels for angiographic procedures, Catalog #: 4100-00.

 FDA DEVICE

syngo.CT software version VA48A_SP5.5 in the following SOMATOM computed tomography models: SOMATOM Definition Edge-Model #10590000; SOMATOM Definition AS Model #8098027; SOMATOM Definition Flash Model #10430603