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Comprehensive® Instrumentation 110028923

by Biomet Orthopedics, Inc.

Ref 110028923

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None ongoing

17 closed

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 7 Nov 2026. What this means

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number889024AER25 Basic UDI-DI 00887868470097UDI-DIDate29 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00887868470097 UDI-DI Date30 Apr 2021ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

17 recalls · FDA

    • Terminated Z-2144-2020 FDA Class II initiated 17 Apr 2020

    Potential presence of elevated endotoxin levels that exceed the specification limit

    • Terminated Z-1750-2020 FDA Class II initiated 13 Mar 2020

    There were unknown bioburden levels prior to sterilization, which may affect sterility of the product.

    • Terminated Z-1859-2017 FDA Class II initiated 17 Feb 2017

    Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.

    • Terminated Z-1103-2017 FDA Class I initiated 20 Dec 2016 on shared 510(k) K080642

    Higher than anticipated rate of fracturing due to design. Risk of revision surgery due to fracturing.

    • Terminated Z-1548-2013 FDA Class II initiated 15 May 2013 on shared 510(k) K080642

    Biomet has initiated this action following an investigation which identified that the slot on the resection guide is offset in the wrong direction. When the slot on the resection guide is offset in the wrong direction, the Steinman pin that is intended to hold the guide into place may not come into contact with the bone.

  • 10 recalls, same reason

    • Terminated Z-2545-2011 FDA Unclassified (pre-2012) initiated 22 Apr 2011
    • Terminated Z-2541-2011 FDA Unclassified (pre-2012) initiated 22 Apr 2011
    • Terminated Z-2549-2011 FDA Unclassified (pre-2012) initiated 22 Apr 2011
    • Terminated Z-2548-2011 FDA Unclassified (pre-2012) initiated 22 Apr 2011
    • Terminated Z-2547-2011 FDA Unclassified (pre-2012) initiated 22 Apr 2011
    • Terminated Z-2550-2011 FDA Unclassified (pre-2012) initiated 22 Apr 2011
    • Terminated Z-2546-2011 FDA Unclassified (pre-2012) initiated 22 Apr 2011
    • Terminated Z-2542-2011 FDA Unclassified (pre-2012) initiated 22 Apr 2011
    • Terminated Z-2544-2011 FDA Unclassified (pre-2012) initiated 22 Apr 2011
    • Terminated Z-2543-2011 FDA Unclassified (pre-2012) initiated 22 Apr 2011

    The firm is initiating this recall following an investigation which identified the rare possibility that certain units of Comprehensive Reverse Shoulder Humeral Trays may contain a locking ring that is incorrectly assembled.

  • 2 recalls, same reason

    • Terminated Z-0712-2011 FDA Unclassified (pre-2012) initiated 13 Sep 2010
    • Terminated Z-0713-2011 FDA Unclassified (pre-2012) initiated 13 Sep 2010

    The firm received complaints regarding fracturing of the device.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Comprehensive® Instrumentation
Generic Name
Instrument tray, reusable
Device Name
Biomet Orthopedics Cases and Trays
Model / Ref / Catalog
110028923
Primary DI / UDI-DI
00887868470097
Basic UDI-DI
889024AER25
Direct Marketing DI
00887868470097
510(k) Number
FDA Product Code
PHX, KWS
EMDN Code
L99 Surgical instruments, reusable - other
GMDN Term
Instrument tray, reusable
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
888.3660
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Related devices

Category: Instrument tray, reusable

Cleared under the same submission (K080642)

Show all (12)

Other devices from Biomet Orthopedics, Inc.

See all devices from Biomet Orthopedics, Inc. →

Properties

  • Reusable
  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (20)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No