FDA-Device2017-11-15Class II
Delta Cup Beater Positioner - Aligner, model # 9057.20.555 Used during implantation of the Delta Acetabular System
Limacorporate S.p.A
Hazard
An internal analysis on complaints received indicated that the welding process may have been performed sub optimally in the 12 lot # involved , leading to reduced mechanical strength of the device and possible breakage during impaction when the instrument is subjected to repeated multi-axial stresses.
Sold states
Worldwide Distribution - US Distribution and to the countries of : Australia, Austria, Belgium, Brazil, Czech Republic, Germany, Italy, New Zealand, Poland, Russia, Slovakia, Slovenia, Spain, South Africa, Switzerland, Turkey, UK and Germany
Affected count
20 units in (US)
Manufactured in
Via Nazionale 52, Frazione Villanova, San Daniele del Friuli, N/A, Italy
Products
Delta Cup Beater Positioner - Aligner, model # 9057.20.555 Used during implantation of the Delta Acetabular System
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0068-2018Don't want to check this manually?
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