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ANSPACH|EG1

by Synthes GmbH Switzerland EUDAMEDGUDID

Ref SHORT-G1

Product code HBCEMDN Z12130580

Regulatory status

as of 25 Oct 2026

Recall ongoing. 9 ongoing FDA recalls. See recalls

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number7611819a00618JZ Basic UDI-DIDate30 Jul 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00845384016298 UDI-DIDate9 Sep 2016ListedStatusListed

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Certificates: none listed in EUDAMED

Recalls

11 recalls · 9 ongoing · FDA

  • 9 recalls, same reason

    • Ongoing Z-0920-2023 FDA Class II initiated 7 Dec 2022
    • Ongoing Z-0923-2023 FDA Class II initiated 7 Dec 2022
    • Ongoing Z-0918-2023 FDA Class II initiated 7 Dec 2022
    • Ongoing Z-0924-2023 FDA Class II initiated 7 Dec 2022
    • Ongoing Z-0919-2023 FDA Class II initiated 7 Dec 2022
    • Ongoing Z-0916-2023 FDA Class II initiated 7 Dec 2022
    • Ongoing Z-0922-2023 FDA Class II initiated 7 Dec 2022
    • Ongoing Z-0917-2023 FDA Class II initiated 7 Dec 2022
    • Ongoing Z-0921-2023 FDA Class II initiated 7 Dec 2022

    Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommended inspection intervals provided in the IFU may result in serious patient injury

    • Terminated Z-2253-2016 FDA Class II initiated 15 Jun 2016

    The graphics at the attachment interface indicating locked and unlocked position are reversed.

    • Terminated Z-1037-2015 FDA Class II initiated 10 Dec 2014

    Customer complaint indicating the color bands on the MIA16-G1 were not correct.

Specification

EUDAMED · GUDID · synced 23 Oct 2026

Trade Name
ANSPACH|EG1 EUDAMED
Na GUDID
Generic Name
Burring power tool attachment
Device Name
G1 Straight and Angle Attachments
Model / Ref / Catalog
SHORT-G1
Primary DI / UDI-DI
00845384016298
Basic UDI-DI
7611819a00618JZ
Direct Marketing DI
00845384016298
510(k) Number
FDA Product Code
HBC, ERL
EMDN Code
Z12130580 Motorised orthopaedic surgery system instruments - hardware accessories
GMDN Term
Burring power tool attachment
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
882.4360, 874.4250
Market of Registration
Belgium
Commercial Distribution
Not 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

Manufacturer details

EUDAMED SRN
CH-MF-000013345
Authorised representative
DePuy Ireland UC IE-AR-000009328

Other devices from Synthes GmbH

See all devices from Synthes GmbH →

Properties & raw data

Show properties, registry sources and raw records
  • Prescription Use
  • Serial Number
Other properties (22)
  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: 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
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No

Sources (2)

  • EUDAMED fe46c197-ea38-408c-ba4b-2488782821b1 61 fields · synced 23 Oct 2026
  • FDA UDI 2fd016cf-c3cd-4149-b7d5-4cd3f3953596 37 fields · synced 23 Oct 2026