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ANSPACH Dissection Tools

by Synthes GmbH 417 variants

Ref S-15D-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Withdrawn Withdrawn in European Union.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Was authorized under CE MDR, withdrawn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Withdrawn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

None ongoing

39 closed

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08453840a0018D6 Basic UDI-DI 00845384012870UDI-DIDate30 Jul 2025RegisteredStatusWithdrawn No longer placed on the EU market
United StatesGUDID listing GUDID Number00845384012870 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

39 recalls · FDA

    • Terminated Z-2837-2016 FDA Class II initiated 26 Aug 2016

    Product Code L- 7B-G1 was inadvertently released off of hold status and the affected products were distributed.

  • 3 recalls, same reason

    • Terminated Z-2840-2016 FDA Class II initiated 26 Aug 2016
    • Terminated Z-2838-2016 FDA Class II initiated 26 Aug 2016
    • Terminated Z-2839-2016 FDA Class II initiated 26 Aug 2016

    The firm discovered on March 4, 2016 that several product codes were inadvertently left off of Hold 1503.

  • 34 recalls, same reason

    • Terminated Z-2283-2015 FDA Class II initiated 13 Apr 2015
    • Terminated Z-2307-2015 FDA Class II initiated 13 Apr 2015
    • Terminated Z-2294-2015 FDA Class II initiated 13 Apr 2015
    • Terminated Z-2282-2015 FDA Class II initiated 13 Apr 2015
    • Terminated Z-2284-2015 FDA Class II initiated 13 Apr 2015
    • Terminated Z-2302-2015 FDA Class II initiated 13 Apr 2015
    • Terminated Z-2297-2015 FDA Class II initiated 13 Apr 2015
    • Terminated Z-2309-2015 FDA Class II initiated 13 Apr 2015
    • Terminated Z-2288-2015 FDA Class II initiated 13 Apr 2015
    • Terminated Z-2313-2015 FDA Class II initiated 13 Apr 2015
    • Terminated Z-2292-2015 FDA Class II initiated 13 Apr 2015
    • Terminated Z-2280-2015 FDA Class II initiated 13 Apr 2015
    • Terminated Z-2301-2015 FDA Class II initiated 13 Apr 2015
    • Terminated Z-2289-2015 FDA Class II initiated 13 Apr 2015
    • Terminated Z-2306-2015 FDA Class II initiated 13 Apr 2015
    • Terminated Z-2290-2015 FDA Class II initiated 13 Apr 2015
    • Terminated Z-2281-2015 FDA Class II initiated 13 Apr 2015
    • Terminated Z-2295-2015 FDA Class II initiated 13 Apr 2015
    • Terminated Z-2304-2015 FDA Class II initiated 13 Apr 2015
    • Terminated Z-2296-2015 FDA Class II initiated 13 Apr 2015
    • Terminated Z-2286-2015 FDA Class II initiated 13 Apr 2015
    • Terminated Z-2303-2015 FDA Class II initiated 13 Apr 2015
    • Terminated Z-2312-2015 FDA Class II initiated 13 Apr 2015
    • Terminated Z-2305-2015 FDA Class II initiated 13 Apr 2015
    • Terminated Z-2293-2015 FDA Class II initiated 13 Apr 2015
    • Terminated Z-2299-2015 FDA Class II initiated 13 Apr 2015
    • Terminated Z-2287-2015 FDA Class II initiated 13 Apr 2015
    • Terminated Z-2300-2015 FDA Class II initiated 13 Apr 2015
    • Terminated Z-2311-2015 FDA Class II initiated 13 Apr 2015
    • Terminated Z-2298-2015 FDA Class II initiated 13 Apr 2015
    • Terminated Z-2291-2015 FDA Class II initiated 13 Apr 2015
    • Terminated Z-2310-2015 FDA Class II initiated 13 Apr 2015
    • Terminated Z-2285-2015 FDA Class II initiated 13 Apr 2015
    • Terminated Z-2308-2015 FDA Class II initiated 13 Apr 2015

    G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft exposure may be greater.

    • Terminated Z-1377-2013 FDA Class II initiated 4 Mar 2011

    Due to three batches of product may have diamond grit size larger than intended applied to the head of the cutting burr.

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
S-15D-G1
Primary DI / UDI-DI
00845384012870
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