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Comprehensive® SRS Revision 405231

by Biomet Orthopedics, Inc.

Ref 405231

Comprehensive® SRS Revision 405231 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 889024AD4Y5), cleared under FDA 510(k) K111746 on 15 Dec 2011 and listed in FDA GUDID since 27 Oct 2016 (UDI-DI 00880304542365), 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) K111746

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 Number889024AD4Y5 Basic UDI-DI 00880304542365UDI-DIDate30 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00880304542365 UDI-DI Date27 Oct 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK111746 Date15 Dec 2011DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 889024AD4Y5 registered 30 Oct 2026 Active
  • FDA 510(k) K111746 decided 15 Dec 2011 Active
  • FDA GUDID UDI-DI 00880304542365 listed 27 Oct 2016 Listed

Recalls

1 recall · FDA

    • Terminated Z-1173-2018 FDA Class II initiated 28 Feb 2018

    During assembly, an SRS Humeral Distal Body implant failed to engage correctly at the point of reduction with a Discovery Elbow System Humeral Condyle. A mismatch between the screw holes in the Humeral Body & Elbow Condyle affects assembly during surgery. If the product has already been implanted, no action is required. The mismatch is estimated to prevent screw engagement in less than 1% of cases.

Timeline

4 dated events

  1. Cleared FDA 510(k) K111746
  2. Listed FDA GUDID 00880304542365
  3. Recall initiated FDA recalls Z-1173-2018
  4. Registered EUDAMED 889024AD4Y5

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® SRS Revision
Generic name
Orthopaedic implant impactor, reusable
Device name
Biomet Proximal Body Impactors
Model / Ref / Catalog
405231
Primary DI / UDI-DI
00880304542365
Basic UDI-DI
889024AD4Y5
Direct marketing DI
00880304542365
510(k) Number
FDA product code
KWS, KWT, JDC, MBF
EMDN code
Z12021199 Orthopaedic endoscopy instruments - other
GMDN term
Orthopaedic implant impactor, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
888.3660, 888.3650, 888.3150, 888.3670
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 impactor, reusable

Cleared under the same submission (K111746)

and 8 more cleared under K111746

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)