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Comprehensive® Vrs 110019067

by Biomet Orthopedics, Inc.

Ref 110019067

Comprehensive® Vrs 110019067 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 1 Nov 2026 (Basic UDI-DI 889024-ZB002631-FY), cleared under FDA 510(k) K202232 on 19 Feb 2021 (1 earlier submission) and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00880304829527), 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

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K202232

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number889024-ZB002631-FY Basic UDI-DI 00880304829527UDI-DIDate1 Nov 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK202232 Date19 Feb 2021DecidedStatusActive
United StatesGUDID listing GUDID Number00880304829527 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 889024-ZB002631-FY registered 1 Nov 2026 Active
  • FDA 510(k) K202232 decided 19 Feb 2021 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00880304829527 listed 24 Sep 2016 Listed

Recalls

1 recall · FDA

    • Terminated Z-2300-2020 FDA Class II initiated 11 May 2020

    The product is being recalled due to the central screw drill seizing inside the Comprehensive VRS Inserter, which may lead to an extension of surgery to find a replacement device.

Timeline

5 dated events

  1. Cleared FDA 510(k) K152754
  2. Listed FDA GUDID 00880304829527
  3. Recall initiated FDA recalls Z-2300-2020
  4. Cleared FDA 510(k) K202232
  5. Registered EUDAMED 889024-ZB002631-FY

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  • Withdrawn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
Comprehensive® Vrs
Generic name
Orthopaedic inorganic implant inserter/extractor, reusable
Device name
Comp VRS Extractor
Model / Ref / Catalog
110019067
Primary DI / UDI-DI
00880304829527
Basic UDI-DI
889024-ZB002631-FY
Direct marketing DI
00880304829527
510(k) Number
FDA product code
PHX
EMDN code
L091101 Orthopaedic prostheses and traumatological implants extractors, reusable
GMDN term
Orthopaedic inorganic implant inserter/extractor, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
888.3660
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 inorganic implant inserter/extractor, reusable

Cleared under the same submission (K152754)

and 8 more cleared under K152754

Cleared under the same submission (K202232)

and 7 more cleared under K202232

Similar devices in this category

Other devices filed under ORTHOPAEDIC PROSTHESES AND TRAUMATOLOGICAL IMPLANTS EXTRACTORS, REUSABLE.

Other devices from Biomet Orthopedics, Inc.

See all devices from Biomet Orthopedics, Inc. →

Properties

  • Sterilise before use
  • Reusable
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Lot / batch number
Other properties (20, all answered No)