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Veritas rTSA Instrumentation 5500-H42U3

by Restor3D

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

1 ongoing

This device is named in the recall

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 Number00840097535999 UDI-DI Date14 May 2026ListedStatusListed GUDID: in commercial distribution

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2987-2026 FDA Class II initiated 30 Jun 2026

    Due to incorrect machining of peripheral screw hole resulting in potential for improper engagement of the peripheral screws.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Veritas rTSA Instrumentation
Generic Name
Reverse shoulder cup prosthesis trial, reusable
Model / Reference
5500-H42U3
Primary DI / UDI-DI
00840097535999
510(k) Number
FDA Product Code
PHX
GMDN Term
Reverse shoulder cup prosthesis trial, reusable
Device Class
Class II
Regulation Number
888.3660
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Cleared under the same submission (K243643)

Show all (12)

Other devices from Restor3D

See all devices from Restor3D →

Properties

  • Prescription Use
  • Serial Number

Other properties (12)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No