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Synthes (USA) Ria System - Expanded Indications

by Synthes (Usa) 510(k)

Active United States Open recall

510(k) K042899

Regulatory status

as of 28 Oct 2026

Recall ongoing. 1 ongoing FDA recall names this device. See recalls

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK042899 Date16 Mar 2005ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

18 recalls · 1 ongoing · FDA

    • Ongoing Z-1237-2024 FDA Class II initiated 24 Jan 2024

    Products not sterilized, sterility cannot be confirmed

  • 17 recalls, same reason

    • Terminated Z-0573-2021 FDA Class II initiated 19 Nov 2020
    • Terminated Z-0571-2021 FDA Class II initiated 19 Nov 2020
    • Terminated Z-0574-2021 FDA Class II initiated 19 Nov 2020
    • Terminated Z-0577-2021 FDA Class II initiated 19 Nov 2020
    • Terminated Z-0581-2021 FDA Class II initiated 19 Nov 2020
    • Terminated Z-0580-2021 FDA Class II initiated 19 Nov 2020
    • Terminated Z-0585-2021 FDA Class II initiated 19 Nov 2020
    • Terminated Z-0586-2021 FDA Class II initiated 19 Nov 2020
    • Terminated Z-0575-2021 FDA Class II initiated 19 Nov 2020
    • Terminated Z-0576-2021 FDA Class II initiated 19 Nov 2020
    • Terminated Z-0582-2021 FDA Class II initiated 19 Nov 2020
    • Terminated Z-0587-2021 FDA Class II initiated 19 Nov 2020
    • Terminated Z-0583-2021 FDA Class II initiated 19 Nov 2020
    • Terminated Z-0584-2021 FDA Class II initiated 19 Nov 2020
    • Terminated Z-0572-2021 FDA Class II initiated 19 Nov 2020
    • Terminated Z-0578-2021 FDA Class II initiated 19 Nov 2020
    • Terminated Z-0579-2021 FDA Class II initiated 19 Nov 2020

    RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniques are not followed

Specification

510(k)

510(k) Number
FDA Product Code
HTO
Device Class
Class I
Regulation
21 CFR Part 888.4540
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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