Materialise USA LLC: Medical Device Recall in 2014 - (Recall #: Z-0418-2015)

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:

Zimmer Patient Specific Instrument PERSONA CR Pin Guides (Femur and Tibia) is intended to be used as a surgical instrument to assist in the positioning of Total Knee Replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.

Product Classification:

Class II

Date Initiated: October 16, 2014

Date Posted: December 3, 2014

Recall Number: Z-0418-2015

Event ID: 69632

Reason for Recall:

The box of guides for a specific case arrived intact but contained two (2) femoral guides instead of one (1) femoral guide and one (1) tibial guide. The device did not meet specification: One tibia guide missing and one femur guide contained an edge which was +0.04 mm over specification.

Status: Terminated

Product Quantity: 1

Code Information:

00-5970-000-25 JTOMA-JL-0636-L8 Pin Guide LOT#: 56602902

Distribution Pattern:

Nationwide Distribution to MN only

Voluntary or Mandated:

Voluntary: Firm initiated