DeRoyal SHOULDER ARTHOSCOPY PACK, REF 89-10061.02
FDA Recall #Z-0671-2023 — Class II — November 3, 2022
Product Description
DeRoyal SHOULDER ARTHOSCOPY PACK, REF 89-10061.02
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
N/A
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: Lot 55972430 exp 10/1/2022; Lot 56621455 exp 11/1/2023; Lot 57302780 exp 2/1/2024
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.