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Comprehensive® Instrumentation 110029136

by Biomet Orthopedics, Inc.

Ref 110029136

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None ongoing

5 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 Number889024-ZB002637-GJ Basic UDI-DI 00887868470110UDI-DIDate31 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00887868470110 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

5 recalls · FDA

    • 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.

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  • Withdrawn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
Bone-resection orthopaedic reamer, reusable
Device Name
Comp Rvs Baseplate Reamer
Model / Ref / Catalog
110029136
Primary DI / UDI-DI
00887868470110
Basic UDI-DI
889024-ZB002637-GJ
Direct Marketing DI
00887868470110
510(k) Number
FDA Product Code
KWS, PHX
EMDN Code
L091102 Orthopaedic prostheses reamers and burs, reusable
GMDN Term
Bone-resection orthopaedic reamer, reusable
Device Class
Class IIa 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 IIa
GUDID
Class II

Related devices

Category: Bone-resection orthopaedic reamer, reusable

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Other devices from Biomet Orthopedics, Inc.

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Properties

  • Reusable
  • CMR Substance
  • Prescription Use
  • Lot / Batch Number

Other properties (20)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Reprocessed: 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
  • Manufacturing Date: No