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Arcos® 110010419

by Biomet Orthopedics, Inc.

Ref 110010419

Arcos® 110010419 is a device classified as Class I in the EU and Class II in the US made by Biomet Orthopedics, Inc., registered in EUDAMED on 31 Oct 2026 (Basic UDI-DI 889024ACX2B), cleared under FDA 510(k) K090757 on 25 Sep 2009 and listed in FDA GUDID since 30 Apr 2021 (UDI-DI 00887868465765), active as of 7 Nov 2026. One FDA recall is linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None ongoing

18 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K090757

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number889024ACX2B Basic UDI-DI 00887868465765UDI-DIDate31 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00887868465765 UDI-DI Date30 Apr 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK090757 Date25 Sep 2009DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 889024ACX2B registered 31 Oct 2026 Active
  • FDA 510(k) K090757 decided 25 Sep 2009 Active
  • FDA GUDID UDI-DI 00887868465765 listed 30 Apr 2021 Listed

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.

Timeline

21 dated events

  1. Recall initiated FDA recalls Z-2270-2021
  2. Recall initiated FDA recalls Z-2273-2021
  3. Recall initiated FDA recalls Z-2265-2021
  4. Recall initiated FDA recalls Z-2271-2021
  5. Recall initiated FDA recalls Z-2260-2021
  6. Recall initiated FDA recalls Z-2263-2021
  7. Recall initiated FDA recalls Z-2275-2021
  8. Recall initiated FDA recalls Z-2261-2021
  9. Recall initiated FDA recalls Z-2268-2021
  10. Registered EUDAMED 889024ACX2B

11 earlier events are in the sections above.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Arcos®
Generic name
Orthopaedic prosthesis implantation positioning instrument, reusable
Device name
Biomet Inserter Strike Knob
Model / Ref / Catalog
110010419
Primary DI / UDI-DI
00887868465765
Basic UDI-DI
889024ACX2B
Direct marketing DI
00887868465765
510(k) Number
FDA product code
KWY, KWZ, LPH, JDI, LZO, MEH, MAY
EMDN code
Z12021199 Orthopaedic endoscopy instruments - other
GMDN term
Orthopaedic prosthesis implantation positioning instrument, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
888.3390, 888.3310, 888.3358, 888.3350, 888.3353
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Orthopaedic prosthesis implantation positioning instrument, reusable

Cleared under the same submission (K090757)

and 8 more cleared under K090757

Similar devices in this category

Other devices filed under ORTHOPAEDIC ENDOSCOPY INSTRUMENTS - OTHER.

Other devices from Biomet Orthopedics, Inc.

See all devices from Biomet Orthopedics, Inc. →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (21, all answered No)