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Ringloc Hip System 14-103578

by Biomet Orthopedics, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

3 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 Number00880304229778 UDI-DI Date24 Oct 2015ListedStatusListed GUDID: in commercial distribution

Recalls

3 recalls · FDA

    • Terminated Z-0523-2020 FDA Class II initiated 21 Aug 2019

    Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.

    • Terminated Z-1754-2015 FDA Class III initiated 16 Apr 2015

    Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains incorrect GTIN (Global Trade Identification Number) codes.

    • Terminated Z-1122-2015 FDA Class II initiated 9 Jan 2015

    Biomet recalled the Mallory Head 4 Finned Acetabular Shell 50mm (Lot 364600) and Ringloc + Acetabular Shell Limited Hole Finned 52 mm (Lot 427840) following a mix up in packaging with the two.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Ringloc Hip System
Generic Name
Acetabular shell
Model / Ref / Catalog
14-103578
Primary DI / UDI-DI
00880304229778
510(k) Number
FDA Product Code
MEH, LPH
GMDN Term
Acetabular shell
Device Class
Class II
Regulation Number
888.3353, 888.3358
GUDID distribution status
In Commercial Distribution

Related devices

Category: Acetabular shell

Cleared under the same submission (K030055)

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Cleared under the same submission (K921301)

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Other devices from Biomet Orthopedics, Inc.

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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