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Zimmer Biomet, Inc. recalls Affixus Hip Fracture Nail, LH 130 DEG 11MM X 340MM
Recalled February 7, 2018 · FDA recall Z-0434-2018 · Zimmer Biomet
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. · FDA Class II
Units
638 units
Sold at
US nationwide distribution. Also Portugal and the Netherlands.
Description
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.
Product
Affixus Hip Fracture Nail, LH 130 DEG 11MM X 340MM
Manufacturer(s)
Zimmer Biomet, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →