Materialise N.V. recalls Signature TKA GDE/MDL Set 04-05 (Femur & Tibia) The Signature Patient-Specific Surgical Guides are intended to be used…

Recall date

February 4, 2015

Source

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

Recall number

Z-1287-2015

FDA classification

Class II

Brand / firm

Materialise N.V.

Sold / distributed

Worldwide Distribution to the Netherlands only.

Why it was recalled

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.

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 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.