FDA-Device2022-12-21Class II
DeRoyal SPINAL FUSION PACK, REF 89-7515.14
DeRoyal Industries Inc
Hazard
DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.
Sold states
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
Affected count
30 kits
Manufactured in
200 Debusk Ln, N/A, Powell, TN, United States
Products
DeRoyal SPINAL FUSION PACK, REF 89-7515.14
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0598-2023Don't want to check this manually?
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