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Modification to Synthes (USA) Reamer Irrigator Aspirator (Ria) System

by Synthes (Usa)

510(k) K013527

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK013527 Date21 Dec 2001ClearedStatusActive

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

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

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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