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Comprehensive® Shoulder System 407010

by Biomet Orthopedics, Inc.

Ref 407010

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

1 ongoing

This device is named in the recall

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-ZB002012-EF Basic UDI-DI 00887868505348UDI-DIDate30 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00887868505348 UDI-DI Date19 Mar 2022ListedStatusListed 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

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.

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  • Withdrawn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® Shoulder System
Generic Name
Bone tap, reusable
Device Name
Comp Frac Position Sleeve Tap
Model / Ref / Catalog
407010
Primary DI / UDI-DI
00887868505348
Basic UDI-DI
889024-ZB002012-EF
Direct Marketing DI
00887868505348
510(k) Number
FDA Product Code
HSD, MBF, KWS, KWT
EMDN Code
L091002 Instruments for processing materials for osteosynthesis, reusable
GMDN Term
Bone tap, reusable
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
888.3690, 888.3670, 888.3660, 888.3650
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: Bone tap, reusable

Cleared under the same submission (K193038)

Show all (12)

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