FDA Recall
Terminated
Dual Taper Wedge Pressed Fit Femoral Component. The Dual Taper Wedge is a single use device intended for pressed fit reconstruciton of the femoral portion of severely disable and/or very painful hip joints resulting from osteoarthritis, rheumatoid arthritis, traumatic, arthritis or avascular necrosis where radiographic evidence of sufficient sound bone to seat the prosthesis is present.
Recall: Z-1073-2009
·
Initiated October 31, 2008
Recall
- Recall Number
- Z-1073-2009
- Event Number
- 50520
- Firm
- Stelkast Co
- FEI Number
- 3004142400
- Product Code
- LWJ
- Status
- Terminated
- Root Cause
- Packaging
- Initiated
- October 31, 2008
- Posted
- March 31, 2009
- Terminated
- April 14, 2009
- Address
- 200 Hidden Valley Rd, Mcmurray, PA, 15317-2659
Description
Dual Taper Wedge Pressed Fit Femoral Component. The Dual Taper Wedge is a single use device intended for pressed fit reconstruciton of the femoral portion of severely disable and/or very painful hip joints resulting from osteoarthritis, rheumatoid arthritis, traumatic, arthritis or avascular necrosis where radiographic evidence of sufficient sound bone to seat the prosthesis is present.
Reason
A possible breach of the sterile barrier packaging (Tyvek pouch).
Action
The recalling firm telephoned the distributors to inform them of the problem and the need to return the product.
Distribution
Nationwide Distribution -- states of NC, TX, and WV.
Quantity
187 units