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Plus-Mia E0014802-1

by Smith & Nephew, Inc.

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

2 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 Number00885556621820 UDI-DI Date25 Apr 2016ListedStatusListed GUDID: not in commercial distribution

Recalls

2 recalls · FDA

    • Terminated Z-0730-2019 FDA Class II initiated 7 Jan 2019 on shared 510(k) K123598

    The pin that holds the spring mechanism is not properly mounted. The pin could potentially disassemble.

    • Terminated Z-1008-2017 FDA Class II initiated 16 Nov 2016

    The firm received complaints of cracks in the weld on the head of the mallet. In the reported cases, some of the lead beads and particles escaped from the mallet into the surgical wound.

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  • Withdrawn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
Plus-Mia
Generic Name
Orthopaedic broach
Model / Ref / Catalog
E0014802-1
Primary DI / UDI-DI
00885556621820
510(k) Number
FDA Product Code
JDI
GMDN Term
Orthopaedic broach
Device Class
Class II
Regulation Number
888.3350
GUDID distribution status
Not in Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Cleared under the same submission (K123598)

Show all (12)

Other devices from Smith & Nephew, Inc.

See all devices from Smith & Nephew, Inc. →

Properties

  • Prescription Use
  • Lot / Batch 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
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No