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Metafix Hip Stem 579.0202

by Corin Ltd

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05055343891339 UDI-DI Date13 Apr 2016ListedStatusListed GUDID: in commercial distribution

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1509-2022 FDA Class II initiated 22 Jul 2022

    One MetaFix size 7 collarless stem from batch 478179 which was incorrectly labelled as a MetaFix size 3 collared stem from batch 485630.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Metafix Hip Stem
Generic Name
Coated hip femur prosthesis, modular
Model / Ref / Catalog
579.0202
Primary DI / UDI-DI
05055343891339
510(k) Number
FDA Product Code
MEH, OQI, JDI, KWY, KWL, LZO
GMDN Term
Coated hip femur prosthesis, modular
Device Class
Class II
Regulation Number
888.3353, 888.3350, 888.3390, 888.3360
GUDID distribution status
In Commercial Distribution

Related devices

Category: Coated hip femur prosthesis, modular

Cleared under the same submission (K153381)

Show all (12)

Other devices from Corin Ltd

See all devices from Corin Ltd →

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