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).
FDA Recall Z-0111-2015 · Posted 2014-10-22
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Recalling FirmSignal Medical Corporation
Recall StatusTerminated
Product CodeJWH
Date Initiated2014-09-30
Date Terminated2016-03-14
Product Quantity41
Reason for Recall
Packaging of a device was compromised
Firm 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.
Root Cause
Packaging
Distribution Pattern
Worldwide Distribution - US (Nationwide) in the state of: MO and internationally to: Panama.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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