APPLICATION INSTRUMENT FOR STERNAL ZIPFIX(2015-09-01) — recall 53791
Health Canada — Medical Devices · Canada · 2015-09-24 · Type II
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Archived by the issuing authority — kept for reference
Reported risk: In the specified lots of the application instrument for Sternal Zipfix, the end cap may loosen, thus reducing the tension applied to the implant. Also, the end cap may detach, allowing the tensioning spring to also become detached, and making the instrument non-functional.
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