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EXPert Nail 04.003.009

by Synthes

EXPert Nail 04.003.009 (04003009) is a Class II device made by Synthes, cleared under FDA 510(k) K040336 on 12 Apr 2004 (1 earlier submission) and listed in FDA GUDID since 14 Sep 2015 (UDI-DI 10886982081452), active as of 23 Oct 2026. 2 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

None ongoing

2 closed

Documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10886982081452 UDI-DI Date14 Sep 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK040336 Date12 Apr 2004DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K040336 decided 12 Apr 2004 Active· +1 more in the status table
  • FDA GUDID UDI-DI 10886982081452 listed 14 Sep 2015 Listed

Recalls

2 recalls · FDA

    • Terminated Z-1915-2015 FDA Class II initiated 27 May 2015

    certain lots of the Titanium Recon Screws (6.5mm ) were found to contain the incorrect insert GP0760-A (Synthes Titanium Buttress Locking Plate System), instead of the correct insert GP0706-E (Synthes Titanium Intramedullary Nails and Components).

    • Terminated Z-2058-2013 FDA Class II initiated 2 Nov 2012

    Recall was initiated due to the possibility that the outer pouch was compromised. The product is packaged in two pouches; a sterile, internal pouch within an external pouch. It is the outer, external pouch that may be compromised.

Timeline

5 dated events

  1. Cleared FDA 510(k) K033618
  2. Cleared FDA 510(k) K040336
  3. Recall initiated FDA recalls Z-2058-2013
  4. Recall initiated FDA recalls Z-1915-2015
  5. Listed FDA GUDID 10886982081452

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
EXPert Nail
Generic name
Bone nail implantable cap
Model / Ref / Catalog
04.003.009, 04003009
Primary DI / UDI-DI
10886982081452
510(k) Number
FDA product code
HWC, HSB
GMDN term
Bone nail implantable cap
Device class
Class II
Regulation number
888.3040, 888.3020
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Bone nail end-cap

Cleared under the same submission (K033618)

and 8 more cleared under K033618

Cleared under the same submission (K040336)

and 8 more cleared under K040336

Other devices from Synthes

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    Class II

  • Volt 68.134.111

    Class II

  • Volt 68.134.200

    Class II

  • 68.045.017

    Class II

See all devices from Synthes →

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
Other properties (10, all answered No)