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BiMobile Dual Mobility System - Instruments 184-352/46

by WALDEMAR LINK GmbH & Co. KG

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 Number04026575279531 UDI-DI Date25 Jan 2023ListedStatusListed GUDID: in commercial distribution

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1219-2024 FDA Class II initiated 22 Jan 2024

    Mislabeled: Packaging incorrectly reflects a MobileLink Dual Mobility insert type F when it should reference G may cause a delay in surgery

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
BiMobile Dual Mobility System - Instruments
Generic Name
Orthopaedic prosthesis implantation positioning instrument, reusable
Model / Reference
184-352/46
Primary DI / UDI-DI
04026575279531
510(k) Number
FDA Product Code
LZO, MEH
GMDN Term
Orthopaedic prosthesis implantation positioning instrument, reusable
Device Class
Class II
Regulation Number
888.3353
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Category: Orthopaedic prosthesis implantation positioning instrument, reusable

Cleared under the same submission (K190535)

Show all (12)

Other devices from WALDEMAR LINK GmbH & Co. KG

See all devices from WALDEMAR LINK GmbH & Co. KG →

Properties

  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (11)

  • 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
  • Serial Number: No
  • Expiration Date: No