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ANSPACH|EG1

by Synthes GmbH Switzerland EUDAMEDGUDID

Ref EG1A

Product code ERLEMDN Z12130501

Regulatory status

as of 24 Oct 2026

Recall ongoing. 9 ongoing FDA recalls. See recalls

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08453840a0016D2 Basic UDI-DIDate30 Jul 2025RegisteredStatusWithdrawn No longer placed on the EU market
United StatesGUDID listing GUDID Number00845384017134 UDI-DIDate9 Sep 2016ListedStatusWithdrawn

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
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Withdrawn
  • 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 24 Oct 2026

Trade Name
ANSPACH|EG1 EUDAMED
Na GUDID
Generic Name
Bone/joint surgical power tool motor, electric
Model / Ref / Catalog
EG1A
Primary DI / UDI-DI
00845384017134
Basic UDI-DI
08453840a0016D2
Direct Marketing DI
00845384017134
510(k) Number
FDA Product Code
ERL, HBC
EMDN Code
Z12130501 Motorised orthopaedic surgery systems
GMDN Term
Bone/joint surgical power tool motor, electric
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
874.4250, 882.4360
Market of Registration
Belgium
Commercial Distribution
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

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 & 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 87cc6ada-fba5-40ce-b647-a033ef19097d 61 fields · synced 24 Oct 2026
  • FDA UDI da4d334b-579d-4d82-98d3-435044122a73 37 fields · synced 30 May 2026