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Biolox 6570-0-036

by Howmedica Osteonics Corp.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

4 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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04546540608482 UDI-DI Date24 Sep 2015ListedStatusListed GUDID: in commercial distribution

Recalls

4 recalls · 4 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-0842-2022 FDA Class II initiated 14 Jan 2022
    • Ongoing Z-0843-2022 FDA Class II initiated 14 Jan 2022

    Potential product mix where the size and/or offset of the Biolox delta Ceramic V40 Femoral Head inside the package does not match the package labeling

    • Ongoing Z-0313-2022 FDA Class II initiated 15 Oct 2021 on shared 510(k) K173499

    XXX

    • Ongoing Z-0314-2022 FDA Class II initiated 15 Oct 2021 on shared 510(k) K173499

    There is a potential for the outer white Tyvek lid to debond from the sealed package.

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  • Withdrawn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
Biolox
Generic Name
Ceramic femoral head prosthesis
Model / Ref / Catalog
6570-0-036
Primary DI / UDI-DI
04546540608482
FDA Product Code
LZO
GMDN Term
Ceramic femoral head prosthesis
Device Class
Class II
Regulation Number
888.3353
GUDID distribution status
In Commercial Distribution
Size
Outer Diameter — 36.0 Millimeter

Related devices

Category: Ceramic femoral head prosthesis

Cleared under the same submission (K173499)

Show all (12)

Other devices from Howmedica Osteonics Corp.

See all devices from Howmedica Osteonics Corp. →

Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number

Other properties (9)

  • 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