Materialise N.V. recalls Signature Patient-Specific Surgical Guides; patient specific instruments used as a guide during surgical procedure for…

Recall date

September 23, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0162-2016

FDA classification

Class II

Brand / firm

Materialise N.V.

Sold / distributed

Distributed in MI, ID, TX, and in France.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.