Recall Z-1941-2016— Materialise USA LLC

Name: FDA recall Z-1941-2016
Creator: U.S. Food and Drug Administration
Published: 2016-05-03

Class II · Terminated

Class II FDA medical device recall by Materialise USA LLC, initiated 2016-05-03, terminated 2016-06-28. It names one FDA 510(k) clearance: K102795. Product: Signature TKA GDE/MDL Set 04-05 Patient-specific surgical guide and instrument set.. Reason: 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..

Recalling firm: Materialise USA LLC
Classification: Class II
Status: Terminated
Initiated: 2016-05-03
Terminated: 2016-06-28
Firm location: Plymouth, MI, United States

510(k) clearances named in this recall

1 on FDA's record

K102795 — SIGNATURE PLANNER; SIGNATURE GUIDESMaterialise NV·cleared 2011-02-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.