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Materialise N.V. recalls Signature TKA GDE/MDL Set 04-05 (Femur & Tibia) The Signature Patient-Specific Surgical Guides are intended to be use
Recalled March 25, 2015 · FDA recall Z-1287-2015 · 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. · FDA Class II
Units
1 unit
Sold at
Worldwide Distribution to the Netherlands only.
Description
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.
Product
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.
Manufacturer(s)
Materialise N.V.
Made in
Belgium
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →