TRUMATCH Orthognathics - Genioplasty Surgical Kit, Add-on, Catalog Number: SD980.013

Class I - Dangerous

🏥 Medical Devices Recalled: February 3, 2020 Materialise N.V. Surgical Instruments

What Should You Do?

Check if you have this product:
Lot Number: ME19-ZIK-VIK, UDI: (01)05420060380136(10)ME19ZIKVIK
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: Materialise N.V.
Reason for Recall:: Custom surgical kits contain a plate different than indicated by the package labeling.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: terminated

Product Information

Full Description:

TRUMATCH Orthognathics - Genioplasty Surgical Kit, Add-on, Catalog Number: SD980.013

Product Codes/Lot Numbers:

Lot Number: ME19-ZIK-VIK, UDI: (01)05420060380136(10)ME19ZIKVIK

Distribution:

Distributed in: US, NY

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1485-2020

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