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Comprehensive® Shoulder Instruments 407396

by Biomet Orthopedics, Inc.

Ref 407396

Comprehensive® Shoulder Instruments 407396 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 889024-ZB001987-HM), cleared under FDA 510(k) K193038 on 28 Oct 2020 and listed in FDA GUDID since 2 Apr 2022 (UDI-DI 00887868506086), 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 Number889024-ZB001987-HM Basic UDI-DI 00887868506086UDI-DIDate30 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00887868506086 UDI-DI Date2 Apr 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK193038 Date28 Oct 2020DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 889024-ZB001987-HM registered 30 Oct 2026 Active
  • FDA 510(k) K193038 decided 28 Oct 2020 Active
  • FDA GUDID UDI-DI 00887868506086 listed 2 Apr 2022 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. Cleared FDA 510(k) K193038
  2. Listed FDA GUDID 00887868506086
  3. Recall initiated FDA recalls Z-1403-2025
  4. Registered EUDAMED 889024-ZB001987-HM

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  • Withdrawn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® Shoulder Instruments
Generic name
Orthopaedic implant aiming/guiding block, reusable
Device name
Comp Primary IM Guide Block
Model / Ref / Catalog
407396
Primary DI / UDI-DI
00887868506086
Basic UDI-DI
889024-ZB001987-HM
Direct marketing DI
00887868506086
510(k) Number
FDA product code
MBF, KWS, HSD, KWT
EMDN code
L091002 Instruments for processing materials for osteosynthesis, reusable
GMDN term
Orthopaedic implant aiming/guiding block, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
888.3670, 888.3660, 888.3690, 888.3650
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 implant aiming/guiding block, reusable

Cleared under the same submission (K193038)

and 8 more cleared under K193038

Similar devices in this category

Other devices filed under INSTRUMENTS FOR PROCESSING MATERIALS FOR OSTEOSYNTHESIS, 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)