FDA-Device2015-11-04Class II
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.
Materialise N.V.
Hazard
Potential inaccuracies in the alignment of the guides. Surgery was inaccurately planned because the patient image data was incorrectly processed.
Sold states
Distributed in MI, ID, TX, and in France.
Affected count
4
Manufactured in
15 Technologielaan, N/A, Heverlee, N/A, Belgium
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0162-2016Don't want to check this manually?
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