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Versa-Dial® Shoulder System 407293

by Biomet Orthopedics, Inc.

Ref 407293

Versa-Dial® Shoulder System 407293 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 30 Oct 2026 (Basic UDI-DI 889024ACRZU), cleared under FDA 510(k) K193038 on 28 Oct 2020 and listed in FDA GUDID since 23 May 2020 (UDI-DI 00880304461444), 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

1 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K193038

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 Number889024ACRZU Basic UDI-DI 00880304461444UDI-DIDate30 Oct 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK193038 Date28 Oct 2020DecidedStatusActive
United StatesGUDID listing GUDID Number00880304461444 UDI-DI Date23 May 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 889024ACRZU registered 30 Oct 2026 Active
  • FDA 510(k) K193038 decided 28 Oct 2020 Active
  • FDA GUDID UDI-DI 00880304461444 listed 23 May 2020 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1403-2025 FDA Class II initiated 3 Mar 2025

    Five complaints received where surgeon was unable to remove and/or connect the inserter with the stem during surgery due to excess material remaining within the taper. Issue may lead to clinically significant extension of surgery to find a replacement.

Timeline

4 dated events

  1. Listed FDA GUDID 00880304461444
  2. Cleared FDA 510(k) K193038
  3. Recall initiated FDA recalls Z-1403-2025
  4. Registered EUDAMED 889024ACRZU

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  • Withdrawn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
Versa-Dial® Shoulder System
Generic name
Surgical implant template, reusable
Device name
Biomet Head Sizer Template
Model / Ref / Catalog
407293
Primary DI / UDI-DI
00880304461444
Basic UDI-DI
889024ACRZU
Direct marketing DI
00880304461444
510(k) Number
FDA product code
KWS, KWT, MBF, HSD
EMDN code
Z12021199 Orthopaedic endoscopy instruments - other
GMDN term
Surgical implant template, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
888.3660, 888.3650, 888.3670, 888.3690
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: Surgical implant template, reusable

Cleared under the same submission (K193038)

and 8 more cleared under K193038

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
  • Reusable
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (20, all answered No)