Materialise USA LLC: Medical Device Recall in 2016 - (Recall #: Z-1941-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

Signature TKA GDE/MDL Set 04-05 Patient-specific surgical guide and instrument set.

Product Classification:

Class II

Date Initiated: May 3, 2016

Date Posted: June 15, 2016

Recall Number: Z-1941-2016

Event ID: 74213

Reason for Recall:

A patient specific case of Signature Personalized Patient Care System Knee Guides included a femur guide which does not match the patient associated with the case. If the issue is not identified prior to surgery, the personalized patient specific guide would provide an improper fit and would not be able to be used.

Status: Terminated

Product Quantity: 1

Code Information:

Lot #154970

Distribution Pattern:

One consignee, Indiana.

Voluntary or Mandated:

Voluntary: Firm initiated