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Comprehensive Reverse Shoulder Instrument 406209

by Biomet Orthopedics, Inc.

Ref 406209

Comprehensive Reverse Shoulder Instrument 406209 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 889024-ZB002649-GV), cleared under FDA 510(k) K193373 on 15 Apr 2020 (2 earlier submissions) and listed in FDA GUDID since 28 Oct 2016 (UDI-DI 00887868505140), active as of 7 Nov 2026. 6 FDA recalls are 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

6 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K193373

+2 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-ZB002649-GV Basic UDI-DI 00887868505140UDI-DIDate31 Oct 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK193373 Date15 Apr 2020DecidedStatusActive
United StatesGUDID listing GUDID Number00887868505140 UDI-DI Date28 Oct 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 889024-ZB002649-GV registered 31 Oct 2026 Active
  • FDA 510(k) K193373 decided 15 Apr 2020 Active· +2 more in the status table
  • FDA GUDID UDI-DI 00887868505140 listed 28 Oct 2016 Listed

Recalls

6 recalls · FDA

    • Terminated Z-1131-2021 FDA Class II initiated 15 Jan 2021

    Zimmer Biomet is conducting a lot specific medical device recall for the Comprehensive Reverse Shoulder Central Screw, 25 MM Length. It has been determined through a complaint investigation that a 40 MM length central screw was packaged and labeled as a 25 MM length central screw.

    • Terminated Z-0619-2021 FDA Class II initiated 25 Nov 2020

    Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.

    • Terminated Z-0093-2021 FDA Class II initiated 2 Sep 2020

    Product potentially being packaged without a taper adapter or baseplate. The package should contain one (1) baseplate and one (1) taper adapter, product may be packaged with two (2) baseplates and no (0) adapters or with no (0) baseplates and two (2) adapters

    • Terminated Z-1615-2020 FDA Class II initiated 25 Feb 2020

    Package is intended to contain one (1) baseplate and one (1) taper adapter; however, devices may be packaged with two (2) baseplates and no (0) adapters.

    • Terminated Z-0972-2019 FDA Class II initiated 21 Dec 2018

    The product was potentially being packaged without a taper adapter.

    • Terminated Z-1208-2015 FDA Class II initiated 7 Jan 2015

    The taper adaptor is missing from the packaging, which may result in a delay in surgery greater than 30 minutes.

Timeline

11 dated events

  1. Cleared FDA 510(k) K132239
  2. Recall initiated FDA recalls Z-1208-2015
  3. Listed FDA GUDID 00887868505140
  4. Recall initiated FDA recalls Z-0972-2019
  5. Recall initiated FDA recalls Z-1615-2020
  6. Cleared FDA 510(k) K193373
  7. Recall initiated FDA recalls Z-0093-2021
  8. Recall initiated FDA recalls Z-0619-2021
  9. Recall initiated FDA recalls Z-1131-2021
  10. Registered EUDAMED 889024-ZB002649-GV

1 earlier event 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
Comprehensive® Reverse Shoulder Instrument EUDAMEDGUDID
Comprehensive Reverse Shoulder Instrument GUDID
Generic name
Orthopaedic inorganic implant inserter/extractor, reusable
Device name
Comp Rvs Glenoid Base Extractor
Model / Ref / Catalog
406209
Primary DI / UDI-DI
00887868505140, 00880304550476
Basic UDI-DI
889024-ZB002649-GV
Direct marketing DI
00887868505140
510(k) Number
FDA product code
KWS, 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 (K120121)

and 8 more cleared under K120121

Cleared under the same submission (K132239)

and 8 more cleared under K132239

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
  • Manufacturing date YesGUDIDNoGUDID
Other properties (19, all answered No)