Materialise USA LLC: Medical Device Recall in 2014 - (Recall #: Z-0628-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

REF 42-411571 QTY 1 CATALOG CAUTION. SEE INSTRUCTIONS FOR USE SIGNATURE M PKA GDE/MDL SET SML-MP DD.....R-FEB55RKA-T JA-A01 05551 PKA POST CUT SML-PKA MICROPLASTY CUSTOM-MADE DEVICE non-sterile The Signature Personalized Patient Care System includes the patient-specific Signature Guides which are patient specific instruments (guides are considered custom-made per EU definition) intended for use during the surgical procedure for total and partial knee arthroplasty.

Product Classification:

Class II

Date Initiated: November 26, 2013

Date Posted: January 15, 2014

Recall Number: Z-0628-2014

Event ID: 67039

Reason for Recall:

Shipped femur guide contained a non-conformance which could possibly impact fit of the drill insert.

Status: Terminated

Product Quantity: 1

Code Information:

Lot 094929

Distribution Pattern:

US Distribution: MO only.

Voluntary or Mandated:

Voluntary: Firm initiated