DeRoyal TRACECART SHOULDER ARTHROSCOPY TRACECART, REF 53-1962.02
FDA Recall #Z-0706-2023 — Class II — November 3, 2022
Product Description
DeRoyal TRACECART SHOULDER ARTHROSCOPY TRACECART, REF 53-1962.02
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
117 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: 56296761 exp 10/01/2023; 56717318 exp 11/01/2023; 57136671 exp 11/01/2023; 57225673 exp 11/01/2023; 57225817 exp 02-01-2024; 57455920 exp 02-01-2024; 57646161 exp 02-01-2024; 57889699 exp 02-01-2024; 58003853 exp 02-01-2024
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.