DeRoyal TRACECART POSTEROR LUMBAR FUSION TRACECART, REF 53-1961.02
FDA Recall #Z-0707-2023 — Class II — November 3, 2022
Product Description
DeRoyal TRACECART POSTEROR LUMBAR FUSION TRACECART, REF 53-1961.02
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
336 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: 56169083 exp 12/01/2023; 56357092 exp 12/01/2023; 56481018 exp 12/01/2023; 56538205 exp 09/01/2023; 56873265 exp 09/01/2023; 56895966 exp 09/01/2023; 56942611 exp 03/01/2024; 57088584 exp 03/01/2024; 57088592 exp 03/01/2024; 57180516 exp 03/01/2024; 57270562 exp 03/01/2024; 57313163 exp 03/01/2024; 57313171 exp 03/01/2024; 57492608 exp 03/01/2024; 57646152 exp 03/01/2024; 57681329 exp 03/01/2024; 57717598 exp 03/01/2024; 57788708 exp 03/01/2024; 57889681 exp 03/01/2024; 57928563 exp 03/01/2024; 57960070 exp 03/01/2024; 58003845 exp 04/01/2024; 58032523 exp 04/01/2024
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.