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BIOLOX® Delta Hip System 650-1057

by Biomet Orthopedics, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

2 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 Number00887868248580 UDI-DI Date13 Nov 2018ListedStatusListed GUDID: in commercial distribution

Recalls

4 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-3133-2024 FDA Class II initiated 8 Aug 2024
    • Ongoing Z-3132-2024 FDA Class II initiated 8 Aug 2024

    Mislabeled: Incorrect sleeve in the packaging. The outer packaging is labeled as a standard neck sleeve, however, the product within the box is a -6mm neck sleeve, and vice versa. The neck of the sleeve can be identified by the device etching as either STD or -6

  • 2 recalls, same reason

    • Terminated Z-0301-2018 FDA Class II initiated 5 Jun 2017
    • Terminated Z-0302-2018 FDA Class II initiated 5 Jun 2017

    Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be incorrect.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
BIOLOX® Delta Hip System
Generic Name
Ceramic femoral head prosthesis
Model / Ref / Catalog
650-1057
Primary DI / UDI-DI
00887868248580
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

Related devices

Category: Ceramic femoral head prosthesis

Cleared under the same submission (K082996)

Show all (12)

Other devices from Biomet Orthopedics, Inc.

See all devices from Biomet Orthopedics, 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