Recall Z-0162-2016— Materialise N.V.

Name: FDA recall Z-0162-2016
Creator: U.S. Food and Drug Administration
Published: 2015-09-23

Class II · Terminated

Class II FDA medical device recall by Materialise N.V., initiated 2015-09-23, terminated 2016-02-12. It names one FDA 510(k) clearance: K102795. Product: Signature Patient-Specific Surgical Guides; patient specific instruments used as a guide during surgical procedure for total and partial knee arthroplasty. Part of the Signature Personalized Patient Care System.. Reason: Potential inaccuracies in the alignment of the guides. Surgery was inaccurately planned because the patient image data was incorrectly processed..

Recalling firm: Materialise N.V.
Classification: Class II
Status: Terminated
Initiated: 2015-09-23
Terminated: 2016-02-12
Firm location: Heverlee, N/A, 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 Patient-Specific Surgical Guides; patient specific instruments used as a guide during surgical procedure for total and partial knee arthroplasty. Part of the Signature Personalized Patient Care System.

Reason for recall

Potential inaccuracies in the alignment of the guides. Surgery was inaccurately planned because the patient image data was incorrectly processed.

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