Home / Recalls / Materialise N.V. / Z-1287-2015

Z-1287-2015 Class II Terminated

Recalled by Materialise N.V. — Heverlee

Recall Details

Product Type
Devices
Report Date
March 25, 2015
Initiation Date
February 4, 2015
Termination Date
October 30, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1 unit

Product Description

Signature TKA GDE/MDL Set 04-05 (Femur & Tibia) The Signature Patient-Specific Surgical Guides are intended to be used as part of the Signature Personalized Patient Care System. Lt is intended to be used as a guide during the surgical procedure for total and partial knee arthroplasty.

Reason for Recall

Images belonging to a different patient were used for the production of the patient specific surgical guide. The incorrect guide may cause a delay in surgery to accommodate the preparation and use of traditional instrumentation.

Distribution Pattern

Worldwide Distribution to the Netherlands only.

Code Information

Lot# 124471

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  • 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)