Trigen 71675040

• FDA 510(k) K210980 decided 14 Nov 2022 Active· +1 more in the status table
• FDA GUDID UDI-DI 03596010524720 listed 13 Nov 2017 Listed

• • Ongoing Z-2456-2026 FDA Class II ·initiated 16 Mar 2026 ·on shared 510(k) K210980

  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 ·on shared 510(k) K210980

  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-2443-2023 FDA Class II ·initiated 24 Jul 2023 ·on shared 510(k) K210980
  • Ongoing Z-2444-2023 FDA Class II ·initiated 24 Jul 2023 ·on shared 510(k) K210980

  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.

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

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

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

1. 2 Jul 2014 Recall initiated FDA recalls Z-2258-2014
2. 24 Oct 2017 Recall initiated FDA recalls Z-0097-2018
3. 13 Nov 2017 Listed FDA GUDID 03596010524720
4. 2 Nov 2020 Recall initiated FDA recalls Z-0772-2021
5. 22 Apr 2022 Recall initiated FDA recalls Z-1133-2022
6. 14 Nov 2022 Cleared FDA 510(k) K210980
7. 24 Jul 2023 Recall initiated FDA recalls Z-2443-2023
8. 24 Jul 2023 Recall initiated FDA recalls Z-2444-2023
9. 18 Mar 2025 Recall initiated FDA recalls Z-1806-2025
10. 16 Mar 2026 Recall initiated FDA recalls Z-2456-2026

3 earlier events are in the sections above.

Trade name

Trigen

Generic name

Bone nail implantable cap

Model / Ref / Catalog

71675040

Primary DI / UDI-DI

03596010524720

510(k) Number

K040212 ↗

K210980 ↗

FDA product code

JDS

GMDN term

Bone nail implantable cap

Device class

Class II

Regulation number

888.3030

GUDID distribution status

In Commercial Distribution

MRI safety

MR Conditional

Category: Bone nail end-cap

• Real Intelligence ROB30801

  Class II

  FDA 510(k) K252841 Active Cleared 5 Dec 2025 GUDID on market

• Real Intelligence ROB30007

  Class II

  FDA 510(k) K252841 Active Cleared 5 Dec 2025 GUDID on market

• PyroCarbon Modular Radial Head TRL-310-01

  Class II

  FDA 510(k) K032686 Active Cleared 22 Oct 2003 GUDID on market

• PyroCarbon Modular Radial Head TRL-310-04

  Class II

  FDA 510(k) K032686 Active Cleared 22 Oct 2003 GUDID on market

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