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ANSPACH Dissection Tools

by Synthes GmbH 417 variants

Ref M-14R-G1

Withdrawn Withdrawn in European Union. No longer placed on the EU market.

Was authorized under CE MDR, withdrawn

Ended

Withdrawn

Date not published (CE MDR)

FDA recalls

9 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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08453840a0018D6 Basic UDI-DI 00845384016571UDI-DIDate30 Jul 2025RegisteredStatusWithdrawn No longer placed on the EU market
United StatesGUDID listing GUDID Number00845384016571 UDI-DI Date9 Sep 2016ListedStatusListed GUDID: not 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

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.

Coverage

2 jurisdictions

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  • Withdrawn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  • European Union CE/MDR Withdrawn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

Specification

EUDAMED · GUDID

Generic Name
Cranial bur, single-use
Device Name
Cutting Tools - Dissection Tools
Model / Ref / Catalog
M-14R-G1
Primary DI / UDI-DI
00845384016571
Basic UDI-DI
08453840a0018D6
510(k) Number
FDA Product Code
ERL, HBC
EMDN Code
Z12130580 Motorised orthopaedic surgery system instruments - hardware accessories
GMDN Term
Cranial bur, single-use
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
874.4250, 882.4360
EU market of registration
Belgium
GUDID distribution status
Not in Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
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

  • Sterile
  • Single Use
  • CMR Substance
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (18)

  • Implantable: No
  • Reusable: 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
  • Manufacturing Date: No