Z-0710-04

Biolox Ceramic Head XL

Name: Z-0710-04 Biolox Ceramic Head XL
Creator: Plus Orthopedics
Published: 2004-02-10
License: https://open.fda.gov/license/

Plus Orthopedics / initiated 2004-02-10 / Terminated

FDA source

Plus Orthopedics began a recall of Biolox Ceramic Head XL on 2004-02-10. The reason FDA records is "Ceramic femoral ball heads break". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0710-04
Status: Terminated
Initiated: 2004-02-10
Posted: 2004-07-20
Terminated: 2004-03-30
Recalling firm: Plus Orthopedics
Product: Biolox Ceramic Head XL
Product code: LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Reason for recall: Ceramic femoral ball heads break.
FDA root cause: Other
Action: Firm is sending Dear Doctor letters to implanting physicians to have them evaluate their patients. Letters were sent 2/10/2004.
Quantity in commerce: 7 implanted.
Distribution: To phyisicians in TX, CT, IN
Product codes and lots: None apply.

Product code LZO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)