Recall Z-1287-2015— Materialise N.V.

Name: FDA recall Z-1287-2015
Creator: U.S. Food and Drug Administration
Published: 2015-02-04

Class II · Terminated

Class II FDA medical device recall by Materialise N.V., initiated 2015-02-04, terminated 2015-10-30. It names one FDA 510(k) clearance: K102795. Product: 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.. Reason: 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..

Recalling firm: Materialise N.V.
Classification: Class II
Status: Terminated
Initiated: 2015-02-04
Terminated: 2015-10-30
Firm location: Heverlee, Belgium

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 (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.

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.

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