Biolox Ceramic Head XL
FDA Recall Z-0710-04 · Posted 2004-07-20
Recalling FirmPlus Orthopedics
Recall StatusTerminated
Product CodeLZO
Date Initiated2004-02-10
Date Terminated2004-03-30
Product Quantity7 implanted.
Reason for Recall
Ceramic femoral ball heads break.
Firm Action
Firm is sending Dear Doctor letters to implanting physicians to have them evaluate their patients. Letters were sent 2/10/2004.
Root Cause
Other
Distribution Pattern
To phyisicians in TX, CT, IN
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.