FDA-Device2015-03-25Class II
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.
Materialise N.V.
Hazard
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.
Sold states
Worldwide Distribution to the Netherlands only.
Affected count
1 unit
Manufactured in
15 Technologielaan, Heverlee, Belgium
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1287-2015Don't want to check this manually?
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