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Tc-100 71170211

by Smith & Nephew, Inc.

Ref 71170211

Tc-100 71170211 is a device classified as Class I in the EU and Class II in the US made by Smith & Nephew, Inc., registered in EUDAMED on 9 Sep 2026 (Basic UDI-DI 0885556SN000387MK), cleared under FDA 510(k) K123598 on 28 Jun 2013 and listed in FDA GUDID since 28 Sep 2015 (UDI-DI 03596010181701), active as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None ongoing

2 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K123598

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0885556SN000387MK Basic UDI-DI 03596010181701UDI-DIDate9 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03596010181701 UDI-DI Date28 Sep 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK123598 Date28 Jun 2013DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0885556SN000387MK registered 9 Sep 2026 Active
  • FDA 510(k) K123598 decided 28 Jun 2013 Active
  • FDA GUDID UDI-DI 03596010181701 listed 28 Sep 2015 Listed

Recalls

2 recalls · FDA

    • Terminated Z-0730-2019 FDA Class II initiated 7 Jan 2019 on shared 510(k) K123598

    The pin that holds the spring mechanism is not properly mounted. The pin could potentially disassemble.

    • Terminated Z-1008-2017 FDA Class II initiated 16 Nov 2016 on shared 510(k) K123598

    The firm received complaints of cracks in the weld on the head of the mallet. In the reported cases, some of the lead beads and particles escaped from the mallet into the surgical wound.

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

Timeline

5 dated events

  1. Cleared FDA 510(k) K123598
  2. Listed FDA GUDID 03596010181701
  3. Recall initiated FDA recalls Z-1008-2017
  4. Recall initiated FDA recalls Z-0730-2019
  5. Registered EUDAMED 0885556SN000387MK

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Tc-100
Generic name
Surgical implant handling forceps
Device name
Memphis Class IR SNOI-TF-043 Device Forceps L03130402
Model / Ref / Catalog
71170211
Primary DI / UDI-DI
03596010181701
Basic UDI-DI
0885556SN000387MK
510(k) Number
FDA product code
JDG
EMDN code
L03130402 Forceps for external bodies, reusable
GMDN term
Surgical implant handling forceps
Device class
Class I EUDAMED
Class II GUDID
Regulation number
888.3360
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Bone holding forceps

Cleared under the same submission (K123598)

and 8 more cleared under K123598

Similar devices in this category

Other devices filed under FORCEPS FOR EXTERNAL BODIES, REUSABLE.

Other devices from Smith & Nephew, Inc.

See all devices from Smith & Nephew, Inc. →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Lot / batch number
Other properties (21, all answered No)