Recall Z-0664-2009
Stelkast Co · initiated October 7, 2008
Product
Stelkast Dual Taper Wedge Pressed Fit Femoral Component. Hip Prosthesis, Part number SC1439
Codes / lots: Part number SC1439-1000. Lot number 17877-071707 exp 7/2017
Reason for recall
Sterility may be compromised due to breach in packaging.
FDA-determined cause: Package design/selection
Action taken
On 10/7/08, Stelkast telephoned the two customers of the problem and the need to return the products.
Details
- Recall number
- Z-0664-2009
- Initiated
- October 7, 2008
- Posted by FDA
- January 28, 2009
- Terminated
- April 1, 2009
- Product code
- LWJ – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
- Quantity
- 6 units
- Distribution
- USA distribution to dealers in TX and WV.
- Recalling firm
- Stelkast Co, Mcmurray, PA