FDA Recall
Terminated
Citation TMZF HA Hip Stem Right (Femoral Hip Prosthesis) Catalog No. 6265-5116
Recall: Z-0349-03
·
Initiated November 12, 2002
Recall
- Recall Number
- Z-0349-03
- Event Number
- 25085
- Firm
- Howmedica Osteonics Corp
- FEI Number
- 2219689
- Product Code
- MEH
- Status
- Terminated
- Root Cause
- Other
- Initiated
- November 12, 2002
- Posted
- December 19, 2002
- Terminated
- April 4, 2003
- Address
- 359 Veterans Blvd, Rutherford, NJ, 07070
Description
Citation TMZF HA Hip Stem Right (Femoral Hip Prosthesis) Catalog No. 6265-5116
Reason
Hip Stem Fractures in the neck area.
Action
Letters to Surgeons was sent certified mail on Nov. 4, 2002. Letters to Howmedica agents send on Nov. 12, 2002.
Distribution
Product was distributed to hospitals and Howmedica Branch reps throughout the US.
Quantity
16