Zimmer Biomet, Inc. recalls Affixus Hip Fracture Nail, RH 130 DEG 9MM X 420MM
- Recall date
- August 7, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0483-2018
- FDA classification
- Class II
- Brand / firm
- Zimmer Biomet, Inc.
- Sold / distributed
- US nationwide distribution. Also Portugal and the Netherlands.
Why it was recalled
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.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Affixus Hip Fracture Nail, RH 130 DEG 9MM X 420MM
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