Materialise N.V.: Medical Device Recall in 2015 - (Recall #: Z-1287-2015)

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 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.

Product Classification:

Class II

Date Initiated: February 4, 2015

Date Posted: March 25, 2015

Recall Number: Z-1287-2015

Event ID: 70664

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.

Status: Terminated

Product Quantity: 1 unit

Code Information:

Lot# 124471

Distribution Pattern:

Worldwide Distribution to the Netherlands only.

Voluntary or Mandated:

Voluntary: Firm initiated