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Arcos Proximal Inserter Threaded Rod 110010324

by Biomet Orthopedics, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

18 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00880304673663 UDI-DI Date28 Oct 2016ListedStatusListed GUDID: in commercial distribution

Recalls

18 recalls · FDA

  • 17 recalls, same reason

    • Terminated Z-2272-2021 FDA Class II initiated 2 Jun 2021 on shared 510(k) K090757
    • Terminated Z-2267-2021 FDA Class II initiated 2 Jun 2021 on shared 510(k) K090757
    • Terminated Z-2264-2021 FDA Class II initiated 2 Jun 2021 on shared 510(k) K090757
    • Terminated Z-2266-2021 FDA Class II initiated 2 Jun 2021 on shared 510(k) K090757
    • Terminated Z-2269-2021 FDA Class II initiated 2 Jun 2021 on shared 510(k) K090757
    • Terminated Z-2274-2021 FDA Class II initiated 2 Jun 2021 on shared 510(k) K090757
    • Terminated Z-2259-2021 FDA Class II initiated 2 Jun 2021 on shared 510(k) K090757
    • Terminated Z-2262-2021 FDA Class II initiated 2 Jun 2021 on shared 510(k) K090757
    • Terminated Z-2270-2021 FDA Class II initiated 2 Jun 2021 on shared 510(k) K090757
    • Terminated Z-2273-2021 FDA Class II initiated 2 Jun 2021 on shared 510(k) K090757
    • Terminated Z-2265-2021 FDA Class II initiated 2 Jun 2021 on shared 510(k) K090757
    • Terminated Z-2271-2021 FDA Class II initiated 2 Jun 2021 on shared 510(k) K090757
    • Terminated Z-2260-2021 FDA Class II initiated 2 Jun 2021 on shared 510(k) K090757
    • Terminated Z-2263-2021 FDA Class II initiated 2 Jun 2021 on shared 510(k) K090757
    • Terminated Z-2275-2021 FDA Class II initiated 2 Jun 2021 on shared 510(k) K090757
    • Terminated Z-2261-2021 FDA Class II initiated 2 Jun 2021 on shared 510(k) K090757
    • Terminated Z-2268-2021 FDA Class II initiated 2 Jun 2021 on shared 510(k) K090757

    Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention

    • Terminated Z-2820-2018 FDA Class II initiated 8 Jun 2018

    Two lots of the Echo BI-Metric Hip Stem and ARCOS Modular Revision Hip Stem may have been comingled. Potential health consequences include extension of surgery time to find a replacement component.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Arcos Proximal Inserter Threaded Rod
Generic Name
Orthopaedic prosthesis implantation positioning instrument, reusable
Model / Ref / Catalog
110010324
Primary DI / UDI-DI
00880304673663
510(k) Number
FDA Product Code
MEH, LZO, KWY, MAY, LPH, JDI, KWZ
GMDN Term
Orthopaedic prosthesis implantation positioning instrument, reusable
Device Class
Class II
Regulation Number
888.3353, 888.3390, 888.3358, 888.3350, 888.3310
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Category: Orthopaedic prosthesis implantation positioning instrument, reusable

Cleared under the same submission (K090757)

Show all (12)

Other devices from Biomet Orthopedics, Inc.

See all devices from Biomet Orthopedics, Inc. →

Properties

  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No