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Howmedica Osteonics Corp. Recall: Lateral Assembly, Radial Head Impl Assembly, Size 4. Ort

Howmedica Osteonics Corp. Recall: Lateral Assembly, Radial Head Impl Assembly, Size 4. Ort is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Howmedica Osteonics Corp.; Product: Lateral Assembly, Radial Head Impl Assembly, Size 4. Orthopedic implant for replacement of the proximal end of

Recalling firmHowmedica Osteonics Corp.
ProductLateral Assembly, Radial Head Impl Assembly, Size 4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Reason for recallRevision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
ClassificationClass II (moderate — may cause temporary or reversible health consequences)
StatusTerminated
DistributionDistribution US Nationwide.
Recall initiated20171024
Recall numberZ-2676-2018
Categorydevice
StateNJ
CountryUnited States

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