Recall Z-0111-2015 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Signal Medical Corporation
Symmetric Total Knee Femoral Components Product Usage: Symmetric Total Knee Femoral Component is intended for use with Signal Medical Corp. Total Knee System for cemented use INA Total Knee Replacement. The femoral component is made of cobalt chromium alloy (ASTM F75).
| Date | Oct 22, 2014 (initiated Sep 30, 2014) |
| Status | Terminated |
| Reason | Packaging of a device was compromised |
| Root cause | Packaging |
| Action | Signal Medical sent a Notice letter dated September 30, 2014 to customers. Customers were instructed to carefully inspect devices to ensure package integrity before using. If packaging is compromised it should not be used. Return the affected device and packaging to Signal Medical Corporation. Replacement devices with new packaging configuration is shipped to each location with the old packaging configuration in the event that the packaging is found to be compromised. For questions contact Signal Medical Corp. at 1-800-246-6324. |
| Quantity | 41 |
| Distribution | Worldwide Distribution - US (Nationwide) in the state of: MO and internationally to: Panama. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K080199 | SYMMETRIC TOTAL KNEE SYSTEM Signal Medical Corporation, Jul 3, 2008 |