Home / Recalls / Materialise N.V. / Z-2886-2020

Z-2886-2020 Class II Terminated

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

Recall Details

Product Type
Devices
Report Date
September 2, 2020
Initiation Date
July 17, 2020
Termination Date
December 23, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
128

Product Description

Match Point System The Match Point System is intended to by uses as a surgical instrument to assist in the intraoperative positioning of glenoid components used with total and reverse shoulder arthroplasty by referencing anatomic landmarks of the shoulder that are identifiable on preoperative CT-image scans.

Reason for Recall

The procedure side indicated in the top header of the Shoulder Case Planning Report incorrectly indicated the procedure side as "Left" for surgical plans for a "right" procedure side.

Distribution Pattern

Nationwide distribution to: US including PR and International to UK and Australia.

Code Information

ID #s: 804-03-057, 804-25-148, 804-03-058, 804,07,022 UDI #s: E314804030570, E314804251480, E314804070220

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  • 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)