FDA Recall
Terminated
Biolox Ceramic Head XL
Recall: Z-0710-04
·
Initiated February 10, 2004
Recall
- Recall Number
- Z-0710-04
- Event Number
- 28382
- Firm
- Plus Orthopedics
- FEI Number
- 3001237832
- Product Code
- LZO
- Status
- Terminated
- Root Cause
- Other
- Initiated
- February 10, 2004
- Posted
- July 20, 2004
- Terminated
- March 30, 2004
- Address
- 6055 Lusk Blvd, San Diego, CA, 92121
Description
Biolox Ceramic Head XL
Reason
Ceramic femoral ball heads break.
Action
Firm is sending Dear Doctor letters to implanting physicians to have them evaluate their patients. Letters were sent 2/10/2004.
Distribution
To phyisicians in TX, CT, IN
Quantity
7 implanted.