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Phoenix Tibial Nail System 40342

by Biomet Orthopedics, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

3 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00880304505100 UDI-DI Date24 Oct 2015ListedStatusListed GUDID: in commercial distribution

Recalls

3 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-0625-2021 FDA Class II initiated 25 Nov 2020
    • Terminated Z-0627-2021 FDA Class II initiated 25 Nov 2020 on shared 510(k) K063570

    Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.

    • Terminated Z-1819-2016 FDA Class II initiated 1 Apr 2016

    Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the product becomes non-sterile and is used or implanted, it may lead to an infection.

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

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Phoenix Tibial Nail System
Generic Name
Tibia intramedullary nail
Model / Ref / Catalog
40342
Primary DI / UDI-DI
00880304505100
510(k) Number
FDA Product Code
HSB
GMDN Term
Tibia intramedullary nail
Device Class
Class II
Regulation Number
888.3020
GUDID distribution status
In Commercial Distribution

Related devices

Category: Tibia intramedullary nail

Cleared under the same submission (K063570)

Show all (12)

Other devices from Biomet Orthopedics, Inc.

See all devices from Biomet Orthopedics, Inc. →

Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (8)

  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No