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Metafix Hip Stem 3997150

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 Number05055343895597 UDI-DI Date27 Mar 2017ListedStatusListed 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  • Withdrawn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
Metafix Hip Stem
Generic Name
Bone-resection orthopaedic reamer, reusable
Model / Reference
3997150
Primary DI / UDI-DI
05055343895597
510(k) Number
FDA Product Code
LZO, JDI
GMDN Term
Bone-resection orthopaedic reamer, reusable
Device Class
Class II
Regulation Number
888.3353, 888.3350
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Category: Bone-resection orthopaedic reamer, reusable

Cleared under the same submission (K082525)

Show all (12)

Other devices from Corin Ltd

See all devices from Corin Ltd →

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