Recall Z-0710-04 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Plus Orthopedics
Biolox Ceramic Head XL
| Date | Jul 20, 2004 (initiated Feb 10, 2004) |
| Status | Terminated |
| Reason | Ceramic femoral ball heads break. |
| 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 | 7 implanted. |
| Distribution | To phyisicians in TX, CT, IN |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.