FDA-Device2018-02-07Class II
Affixus Hip Fracture Nail, RH 130 DEG 11MM X 400MM
Zimmer Biomet, Inc.
Hazard
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.
Sold states
US nationwide distribution. Also Portugal and the Netherlands.
Affected count
638 units
Manufactured in
56 E Bell Dr, Warsaw, IN, United States
Products
Affixus Hip Fracture Nail, RH 130 DEG 11MM X 400MM
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0469-2018Don't want to check this manually?
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