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Materialise N.V. recalls Signature Patient-Specific Surgical Guides; patient specific instruments used as a guide during surgical procedure for t
Recalled November 4, 2015 · FDA recall Z-0162-2016 · Materialise N.V
Hazard
Potential inaccuracies in the alignment of the guides. Surgery was inaccurately planned because the patient image data was incorrectly processed. · FDA Class II
Units
4
Sold at
Distributed in MI, ID, TX, and in France.
Description
Potential inaccuracies in the alignment of the guides. Surgery was inaccurately planned because the patient image data was incorrectly processed.
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.
Manufacturer(s)
Materialise N.V.
Made in
Belgium
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →