Materialise N.V.: Medical Device Recall in 2015 - (Recall #: Z-0162-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: September 23, 2015

Date Posted: November 4, 2015

Recall Number: Z-0162-2016

Event ID: 72425

Reason for Recall:

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

Status: Terminated

Product Quantity: 4

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated