Symmetric Total Knee Femoral Components Product Usage: Symmetric Total Knee Femoral Component is intended for use with S
FDA device recall Z-0111-2015 · posted 2014-10-22 · Terminated
Recall details
- Recalling firm
- Signal Medical Corporation
- Reason for recall
- Packaging of a device was compromised
- Action taken
- 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.
- Root cause
- Packaging
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 41
- Distribution
- Worldwide Distribution - US (Nationwide) in the state of: MO and internationally to: Panama.
- Date initiated
- 2014-09-30
- Date posted
- 2014-10-22
- Date terminated
- 2016-03-14
- Location
- Marysville, MI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYMMETRIC TOTAL KNEE SYSTEM (K080199) | Signal Medical Corporation | 2008-07-03 |