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Trigen 71676542

by Smith & Nephew, Inc.

Trigen 71676542 is a Class II device made by Smith & Nephew, Inc., cleared under FDA 510(k) K040212 on 20 Feb 2004 and listed in FDA GUDID since 25 Aug 2015 (UDI-DI 00885556038369), active as of 23 Oct 2026. 6 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 ongoing

This device is named in the recall

Documents

510(k) K040212

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00885556038369 UDI-DI Date25 Aug 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK040212 Date20 Feb 2004DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K040212 decided 20 Feb 2004 Active
  • FDA GUDID UDI-DI 00885556038369 listed 25 Aug 2015 Listed

Recalls

6 recalls · 2 ongoing · FDA

    • Ongoing Z-1133-2022 FDA Class II initiated 22 Apr 2022

    Right nails were anodized, marked, and labelled as left nails and vice versa

    • Ongoing Z-0097-2018 FDA Class II initiated 24 Oct 2017

    A single lot of INTERTAN 10S 10 MM X 18 CM 130 D was manufactured with the screw inserted upside down.

    • Terminated Z-0772-2021 FDA Class II initiated 2 Nov 2020

    Manufacturing packaging error.

    • Terminated Z-2258-2014 FDA Class II initiated 2 Jul 2014

    There was an error in manufacturing which resulted in the proximal lag screw hole being positioned incorrectly in several batches of TRIGEN(R); INTERTAN(TM); NAILS.

  • 2 recalls, same reason

    • Terminated Z-1636-2014 FDA Class II initiated 4 Apr 2014
    • Terminated Z-1637-2014 FDA Class II initiated 4 Apr 2014

    A manufacturing error resulted in the set screw being inserted too deep in the affected nails.

Timeline

8 dated events

  1. Cleared FDA 510(k) K040212
  2. Recall initiated FDA recalls Z-1636-2014
  3. Recall initiated FDA recalls Z-1637-2014
  4. Recall initiated FDA recalls Z-2258-2014
  5. Listed FDA GUDID 00885556038369
  6. Recall initiated FDA recalls Z-0097-2018
  7. Recall initiated FDA recalls Z-0772-2021
  8. Recall initiated FDA recalls Z-1133-2022

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Trigen
Generic name
Femur intramedullary nail
Model / Ref / Catalog
71676542
Primary DI / UDI-DI
00885556038369
510(k) Number
FDA product code
JDS
GMDN term
Femur intramedullary nail
Device class
Class II
Regulation number
888.3030
GUDID distribution status
In Commercial Distribution

Related devices

Category: Femur intramedullary nail

Cleared under the same submission (K040212)

and 8 more cleared under K040212

Other devices from Smith & Nephew, Inc.

See all devices from Smith & Nephew, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)