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Corin Metafix Hip Stem 579.2006

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 Number05055196968158 UDI-DI Date17 Aug 2016ListedStatusListed GUDID: in commercial distribution

Recalls

2 recalls · 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.

    • Terminated Z-2609-2021 FDA Class II initiated 28 Jul 2021 on shared 510(k) K082525

    The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the devices.

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  • Withdrawn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
Corin Metafix Hip Stem
Generic Name
Coated hip femur prosthesis, modular
Model / Ref / Catalog
579.2006
Primary DI / UDI-DI
05055196968158
510(k) Number
FDA Product Code
JDI, LZO
GMDN Term
Coated hip femur prosthesis, modular
Device Class
Class II
Regulation Number
888.3350, 888.3353
GUDID distribution status
In Commercial Distribution
Sterilization Method
Radiation Sterilization

Related devices

Category: Coated hip femur prosthesis, modular

Cleared under the same submission (K082525)

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