Home / Recalls / Materialise N.V. / Z-0162-2016

Z-0162-2016 Class II Terminated

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

Recall Details

Product Type
Devices
Report Date
November 4, 2015
Initiation Date
September 23, 2015
Termination Date
February 12, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4

Product Description

Signature Patient-Specific Surgical Guides; patient specific instruments used as a guide during surgical procedure for total and partial knee arthroplasty. Part of the Signature Personalized Patient Care System.

Reason for Recall

Potential inaccuracies in the alignment of the guides. Surgery was inaccurately planned because the patient image data was incorrectly processed.

Distribution Pattern

Distributed in MI, ID, TX, and in France.

Code Information

42422461: Signature SIG CT/TI(A Guides 04-05 Slidex Distal-MP/Premier Tibial & 42422551 : Signature TKA GDE/MDL SET 03-05 MP/Premier Distal- MP/Premier Tibial 42422461 139540 2016-02-17 42-422551 1 391 51 2016-01-14 42422551 1 38805 2016-02-03 42-422551 140787 2016-03-03

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  • 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-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-1287-2015 Class II — Signature TKA GDE/MDL Set 04-05 (Femur & Tibia) The Signature Patient-Specifi (February 4, 2015)