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Z-1485-2020 Class II Terminated

Recalled by Materialise N.V. — Heverlee

FDA device recall Z-1485-2020 was initiated by Materialise N.V. on February 3, 2020 and is designated Class II. Reason for recall: Custom surgical kits contain a plate different than indicated by the package labeling. The recall status is terminated (terminated March 20, 2020). Affected quantity: 1.

Recall Details

Product Type
Devices
Report Date
March 25, 2020
Initiation Date
February 3, 2020
Termination Date
March 20, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1

Product Description

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

Reason for Recall

Custom surgical kits contain a plate different than indicated by the package labeling.

Distribution Pattern

US: NY. OUS: Italy

Code Information

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

Other recalls by Materialise N.V.

  • Z-2287-2023 Class II — ProPlan CMF Patient-Specific Guide, Mandible guides (3A & 3B)-Intended to guide (June 19, 2023)
  • Z-2213-2023 Class II — MRI Biomet Pin Guide for Total Knee Arthroplasty (Zimmer Biomet Patient Specific (April 26, 2023)
  • Z-2886-2020 Class II — Match Point System The Match Point System is intended to by uses as a surgica (July 17, 2020)
  • Z-1484-2020 Class II — TRUMATCH Orthognathic - Full Bimaxillary Surgical Kit, Catalog Number SD980.001 (February 3, 2020)
  • Z-0162-2016 Class II — Signature Patient-Specific Surgical Guides; patient specific instruments used as (September 23, 2015)
  • Z-1287-2015 Class II — Signature TKA GDE/MDL Set 04-05 (Femur & Tibia) The Signature Patient-Specifi (February 4, 2015)

FDA data resources