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BIOLOX delta 71346004

by Smith & Nephew, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

1 ongoing

Recall on shared 510(k) K211176; other models may be affected

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 Number03596010656711 UDI-DI Date30 Aug 2015ListedStatusListed GUDID: in commercial distribution

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0326-2025 FDA Class II initiated 15 Oct 2024 on shared 510(k) K211176

    The Bipolar assembly contains an oversized Retainer Ring.

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  • Withdrawn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 delta
Generic Name
Ceramic femoral head prosthesis
Model / Ref / Catalog
71346004
Primary DI / UDI-DI
03596010656711
510(k) Number
FDA Product Code
LZO
GMDN Term
Ceramic femoral head prosthesis
Device Class
Class II
Regulation Number
888.3353
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional

Related devices

Category: Ceramic femoral head prosthesis

Cleared under the same submission (K100412)

Cleared under the same submission (K211176)

Show all (12)

Other devices from Smith & Nephew, Inc.

See all devices from Smith & Nephew, Inc. →

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