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Trigen 71646134

by Smith & Nephew, Inc.

Trigen 71646134 is a Class II device made by Smith & Nephew, Inc., cleared under FDA 510(k) K210980 on 14 Nov 2022 (1 earlier submission) and listed in FDA GUDID since 25 Aug 2015 (UDI-DI 03596010541406), active as of 23 Oct 2026. 4 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

4 ongoing

This device is named in the recall

Documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK210980 Date14 Nov 2022DecidedStatusActive
United StatesGUDID listing Number03596010541406 UDI-DI Date25 Aug 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • FDA 510(k) K210980 decided 14 Nov 2022 Active· +1 more in the status table
  • FDA GUDID UDI-DI 03596010541406 listed 25 Aug 2015 Listed

Recalls

4 recalls · 4 ongoing · FDA

    • Ongoing Z-2456-2026 FDA Class II initiated 16 Mar 2026

    Humeral nail due to a manufacturing error is missing distal holes and if implanted may lead to revision surgery but, if the missing holes are identified before implantation, an equivalent backup can be used, or a bent nail of the same size, which would require additional surgical steps to address soft tissue/bone preparation, which could lead to a surgical delay of greater than 30 minutes.

    • Ongoing Z-1806-2025 FDA Class II initiated 18 Mar 2025

    Integrated Lag/Compression Screw Kit has a compression screw with hexagon socket that may be undersized, which causes the screw to be non-functional, which would require replacement with another adequate size screw, and exchange may exceed 30 minutes.

  • 2 recalls, same reason

    • Ongoing Z-2444-2023 FDA Class II initiated 24 Jul 2023
    • Ongoing Z-2443-2023 FDA Class II initiated 24 Jul 2023

    A complaint was received indicating that a package contained a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT implant instead of a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT as described on the product label.

Timeline

7 dated events

  1. Cleared FDA 510(k) K040929
  2. Listed FDA GUDID 03596010541406
  3. Cleared FDA 510(k) K210980
  4. Recall initiated FDA recalls Z-2444-2023
  5. Recall initiated FDA recalls Z-2443-2023
  6. Recall initiated FDA recalls Z-1806-2025
  7. Recall initiated FDA recalls Z-2456-2026

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
71646134
Primary DI / UDI-DI
03596010541406
510(k) Number
FDA product code
HSB
GMDN term
Femur intramedullary nail
Device class
Class II
Regulation number
888.3020
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Related devices

Category: Femur intramedullary nail

Cleared under the same submission (K040929)

and 8 more cleared under K040929

Cleared under the same submission (K210980)

and 8 more cleared under K210980

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)