BIOLOX® Delta Hip System 12-115117

by Biomet Orthopedics, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

3 closed

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

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00887868248467 UDI-DI	Date13 Nov 2018Listed	StatusListed GUDID: in commercial distribution

Recalls

3 recalls · FDA

- Terminated Z-2145-2020 FDA Class II initiated 17 Apr 2020
Potential presence of elevated endotoxin levels that exceed the specification limit
2 recalls, same reason
- Terminated Z-1613-2009 FDA Unclassified (pre-2012) initiated 16 Mar 2009
- Terminated Z-1614-2009 FDA Unclassified (pre-2012) initiated 16 Mar 2009
The firm has received reports of fractured heads, requiring revision surgery.

Coverage

1 jurisdiction

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Withdrawn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: 12-115117

Primary DI / UDI-DI: 00887868248467
510(k) Number: K042091
K051411
FDA Product Code: LZO
GMDN Term: Ceramic femoral head prosthesis

Device Class: Class II
Regulation Number: 888.3353
GUDID distribution status: In Commercial Distribution

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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