DeRoyal TRACECART POSTEROR LAMI MICRODISC TRACECART, REF 53-1960.02
FDA Recall #Z-0708-2023 — Class II — November 3, 2022
Product Description
DeRoyal TRACECART POSTEROR LAMI MICRODISC TRACECART, REF 53-1960.02
Reason for Recall
XXX
Recalling Firm
DeRoyal Industries Inc — Powell, TN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
72 kits
Distribution
US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi
Code Information
Lot Numbers: 56573668 exp 45170; 56670564 exp 45170; 56847198 exp 45170; 57564851 exp 45323; 57889672 exp 45323; 58032515 exp 45323;
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.