Home / Recalls / Materialise N.V. / Z-2213-2023

Z-2213-2023 Class II

Recalled by Materialise N.V. — Heverlee, N/A

Recall Details

Product Type
Devices
Report Date
July 26, 2023
Initiation Date
April 26, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2 Guides

Product Description

MRI Biomet Pin Guide for Total Knee Arthroplasty (Zimmer Biomet Patient Specific Instruments (PSI)-- patient-matched device designed to fit the patients anatomy to transfer a patient-specific pre-operative plan to the OR. Ref: KNM-ZB02-00-01

Reason for Recall

The wrong tibia guide was included intended for a different patient case.

Distribution Pattern

International Distribution to countries of: Germany, Netherlands

Code Information

UDI-DI: (01)05420060310027 Lot Number/Case Number: ZB22UHINEF, ZB23MANOLA

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-2886-2020 Class II — Match Point System The Match Point System is intended to by uses as a surgica (July 17, 2020)
  • Z-1485-2020 Class II — TRUMATCH Orthognathics - Genioplasty Surgical Kit, Add-on, Catalog Number: SD980 (February 3, 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)