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ANSPACH Dissection Tools

by Synthes GmbH 417 variants

Ref MA19-2SB

Withdrawn Withdrawn in European Union.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Was authorized under CE MDR, withdrawn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Withdrawn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

None ongoing

31 closed

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 00845384011859UDI-DIDate30 Jul 2025RegisteredStatusWithdrawn No longer placed on the EU market
United StatesGUDID listing GUDID Number00845384011859 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

31 recalls · FDA

  • 7 recalls, same reason

    • Terminated Z-2009-2017 FDA Class II initiated 6 Oct 2016 on shared 510(k) K042783
    • Terminated Z-2003-2017 FDA Class II initiated 6 Oct 2016 on shared 510(k) K042783
    • Terminated Z-2004-2017 FDA Class II initiated 6 Oct 2016 on shared 510(k) K042783
    • Terminated Z-2011-2017 FDA Class II initiated 6 Oct 2016 on shared 510(k) K042783
    • Terminated Z-2007-2017 FDA Class II initiated 6 Oct 2016 on shared 510(k) K042783
    • Terminated Z-2005-2017 FDA Class II initiated 6 Oct 2016 on shared 510(k) K042783
    • Terminated Z-2006-2017 FDA Class II initiated 6 Oct 2016 on shared 510(k) K042783

    Supplied Directions for Use (DFU) did not contain a recommended service interval.

    • Terminated Z-0708-2014 FDA Class II initiated 26 Oct 2012

    During a recent review of documentation Anspach determined that the current directions for use for the MCA cutting burrs and MCA Micro Curved Attachment do not provide clear details regarding the intended use specifically for the MCA burrs. The MCA burrs are intended for use in delicate bone in otologic procedures such as cochleostomy. The use of the device in dense bone removal may result in cu

  • 21 recalls, same reason

    • Terminated Z-0766-2014 FDA Class II initiated 29 Mar 2012
    • Terminated Z-0769-2014 FDA Class II initiated 29 Mar 2012
    • Terminated Z-0768-2014 FDA Class II initiated 29 Mar 2012
    • Terminated Z-0756-2014 FDA Class II initiated 29 Mar 2012
    • Terminated Z-0753-2014 FDA Class II initiated 29 Mar 2012
    • Terminated Z-0750-2014 FDA Class II initiated 29 Mar 2012
    • Terminated Z-0760-2014 FDA Class II initiated 29 Mar 2012
    • Terminated Z-0764-2014 FDA Class II initiated 29 Mar 2012
    • Terminated Z-0758-2014 FDA Class II initiated 29 Mar 2012
    • Terminated Z-0749-2014 FDA Class II initiated 29 Mar 2012
    • Terminated Z-0755-2014 FDA Class II initiated 29 Mar 2012
    • Terminated Z-0765-2014 FDA Class II initiated 29 Mar 2012
    • Terminated Z-0751-2014 FDA Class II initiated 29 Mar 2012
    • Terminated Z-0757-2014 FDA Class II initiated 29 Mar 2012
    • Terminated Z-0761-2014 FDA Class II initiated 29 Mar 2012
    • Terminated Z-0754-2014 FDA Class II initiated 29 Mar 2012
    • Terminated Z-0763-2014 FDA Class II initiated 29 Mar 2012
    • Terminated Z-0762-2014 FDA Class II initiated 29 Mar 2012
    • Terminated Z-0759-2014 FDA Class II initiated 29 Mar 2012
    • Terminated Z-0752-2014 FDA Class II initiated 29 Mar 2012
    • Terminated Z-0767-2014 FDA Class II initiated 29 Mar 2012

    The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools. The recall was initiated after the indications for use were found to be broader than the validation of the MCA Cutting Burrs and its directions for use did not clearly state the correct intended use of the device. After a labeling correction, Anspach Effort, Inc. decide

    • Terminated Z-0715-2014 FDA Class II initiated 29 Mar 2012

    Current directions for use for the MCA cutting burs (item 18-0001) do not provide enough details regarding the intended use specifically for the MCA burrs.

    • Terminated Z-2903-2011 FDA Unclassified (pre-2012) initiated 13 Oct 2010

    On July 30th, 2010 the Anspach Effort, Inc. initiated a voluntary recall on their Anspach Single Use, Sterile Bone Cutting Burrs. A complaint was recieved stating that the product had failed during a procedure.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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
MA19-2SB
Primary DI / UDI-DI
00845384011859
Basic UDI-DI
08453840a0018D6
510(k) Number
FDA Product Code
HBE
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
882.4310
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