Skip to content

Synthes Ria System (Expanded Indications)

by Synthes (USA) Products, LLC 510(k)

Active United States

510(k) K111437

Regulatory status

as of 27 Oct 2026

Recall ongoing. 1 ongoing FDA recall. See recalls

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK111437 Date10 Aug 2011ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

19 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

    • Terminated Z-2092-2015 FDA Class II initiated 28 May 2015

    It was reported that the RIA Drive Shaft, Tube Assembly, and Reamer Head have the potential to break when incorrectly assembled or used improperly. Precautionary statements are being added to the Reamer / Irrigator / Aspirator (RIA) Surgical Technique Guide.

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

Other devices from Synthes (USA) Products LLC

See all devices from Synthes (USA) Products LLC →