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Materialise USA LLC recalls REF 42-411571 QTY 1 CATALOG CAUTION. SEE INSTRUCTIONS FOR USE SIGNATURE M PKA GDE/MDL SET SML-MP DD.....R-FEB55RKA-
Recalled January 15, 2014 · FDA recall Z-0628-2014 · Materialise USA
Hazard
Shipped femur guide contained a non-conformance which could possibly impact fit of the drill insert. · FDA Class II
Units
1
Sold at
US Distribution: MO only.
Description
Shipped femur guide contained a non-conformance which could possibly impact fit of the drill insert.
Product
REF 42-411571 QTY 1 CATALOG CAUTION. SEE INSTRUCTIONS FOR USE SIGNATURE M PKA GDE/MDL SET SML-MP DD.....R-FEB55RKA-T JA-A01 05551 PKA POST CUT SML-PKA MICROPLASTY CUSTOM-MADE DEVICE non-sterile The Signature Personalized Patient Care System includes the patient-specific Signature Guides which are patient specific instruments (guides are considered custom-made per EU definition) intended for use during the surgical procedure for total and partial knee arthroplasty.
Manufacturer(s)
Materialise USA LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →