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Comprehensive® Instruments 110003483

by Biomet Orthopedics, Inc.

Ref 110003483

Comprehensive® Instruments 110003483 is a device classified as Class IIa in the EU and Class II in the US made by Biomet Orthopedics, Inc., registered in EUDAMED on 1 Nov 2026 (Basic UDI-DI 889024-ZB001994-HH), cleared under FDA 510(k) K193038 on 28 Oct 2020 (1 earlier submission) and listed in FDA GUDID since 23 Mar 2021 (UDI-DI 00887868462627), active as of 7 Nov 2026. 5 FDA recalls are 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

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number889024-ZB001994-HH Basic UDI-DI 00887868462627UDI-DIDate1 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00887868462627 UDI-DI Date23 Mar 2021ListedStatusListed 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-ZB001994-HH registered 1 Nov 2026 Active
  • FDA 510(k) K193038 decided 28 Oct 2020 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00887868462627 listed 23 Mar 2021 Listed

Recalls

5 recalls · 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.

    • Terminated Z-2216-2017 FDA Class II initiated 26 Apr 2017

    Zimmer Biomet is conducting a voluntary recall for a single lot of the Modular Hybrid Glenoid Base Large for the Comprehensive Shoulder System after it was determined that two pieces from the lot were moved to finished goods and shipped despite having an open Non-Conformance Report (NCR). The NCR indicated that one piece from the lot had scratches and the other non-confirming threads.

    • 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-1658-2008 FDA Unclassified (pre-2012) initiated 13 Mar 2008

    The glenoid implant may not seat fully on the face of the natural glenoid due to inadequate measurement tolerances (tolerance stack-up) in the design of the cutter. Use of the instrument may lead to incomplete seating of the glenoid implant, elevating the theoretical risk of glenoid loosening, which may lead to early revision surgery. The problem may contribute to early device failure and patien

    • Terminated Z-0660-2013 FDA Class II initiated 6 Dec 12

    Biomet is recalling Part Number PT-113950 PT Hybrid Glenoid Post, following an investigation which identified that the male thread of the post may be oversized. This oversized condition can vary in degree and may lead to the following three events: 1) If the PT Hybrid Glenoid Post is not fully seated into the Hybrid Base and the implant construct is implanted, then a gap of 1-3 mm will be prese

Timeline

9 dated events

  1. Recall initiated FDA recalls Z-0660-2013
  2. Cleared FDA 510(k) K060694
  3. Recall initiated FDA recalls Z-1658-2008
  4. Recall initiated FDA recalls Z-1859-2017
  5. Recall initiated FDA recalls Z-2216-2017
  6. Cleared FDA 510(k) K193038
  7. Listed FDA GUDID 00887868462627
  8. Recall initiated FDA recalls Z-1403-2025
  9. Registered EUDAMED 889024-ZB001994-HH

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® Instruments
Generic name
Orthopaedic implant-instrument extension adaptor, reusable
Device name
Access Quick Release Drill Shaft
Model / Ref / Catalog
110003483
Primary DI / UDI-DI
00887868462627
Basic UDI-DI
889024-ZB001994-HH
Direct marketing DI
00887868462627
510(k) Number
FDA product code
MBF, HSD, KWS, KWT
EMDN code
L091199 Orthopaedic prosthetics instruments, reusable - other
GMDN term
Orthopaedic implant-instrument extension adaptor, reusable
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
888.3670, 888.3690, 888.3660, 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 IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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-instrument extension adaptor, reusable

Cleared under the same submission (K060694)

and 8 more cleared under K060694

Cleared under the same submission (K193038)

and 8 more cleared under K193038

Similar devices in this category

Other devices filed under ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER.

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)