Nov 3, 2022 FDA device enforcement
XXX
Class II Reported ongoing
Distribution: US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minne...
Official source for GEO-MED PODIATRY PACK PGYBK, REF 89-8700.02 Nov 3, 2022 FDA device enforcement
XXX
Class II Reported ongoing
Distribution: US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minne...
Official source for DeRoyal PORT PACK PGYBK, REF 89-8748.05 Nov 3, 2022 FDA device enforcement
XXX
Class II Reported ongoing
Distribution: US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minne...
Official source for GEO-MED BIOPSY TRAY, REF 89-8753.01 Nov 3, 2022 FDA device enforcement
XXX
Class II Reported ongoing
Distribution: US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minne...
Official source for DeRoyal EYE PACK, REF 89-8756.03 Nov 3, 2022 FDA device enforcement
XXX
Class II Reported ongoing
Distribution: US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minne...
Official source for DeRoyal SHOULDER ARTHROSCOPY PACK, REF 89-8777.04 Nov 3, 2022 FDA device enforcement
XXX
Class II Reported ongoing
Distribution: US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minne...
Official source for DeRoyal ACDF PACK, REF 89-8779.03 Nov 3, 2022 FDA device enforcement
DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.
Class II Reported ongoing
Distribution: US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minne...
Official source for DeRoyal TLIF PACK, REF 89-8780.04 Nov 3, 2022 FDA device enforcement
DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.
Class II Reported ongoing
Distribution: US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minne...
Official source for DeRoyal KIT TOTAL HIP, REF 89-8861.07 Nov 3, 2022 FDA device enforcement
XXX
Class II Reported ongoing
Distribution: US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minne...
Official source for DeRoyal KIT EXTREMITY PACK, REF 89-8869.09 Nov 3, 2022 FDA device enforcement
XXX
Class II Reported ongoing
Distribution: US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minne...
Official source for DeRoyal KIT HEART B PACK, REF 89-9042.07 Nov 3, 2022 FDA device enforcement
XXX
Class II Reported ongoing
Distribution: US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minne...
Official source for DeRoyal KIT HEART B PACK, REF 89-9042.08 Nov 3, 2022 FDA device enforcement
XXX
Class II Reported ongoing
Distribution: US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minne...
Official source for DeRoyal LAMINECTOMY SPINAL FUSION PACK, REF 89-9105.08 Nov 3, 2022 FDA device enforcement
XXX
Class II Reported ongoing
Distribution: US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minne...
Official source for DeRoyal LAMINECTOMY SPINAL FUSION PACK, REF 89-9105.09 Nov 3, 2022 FDA device enforcement
XXX
Class II Reported ongoing
Distribution: US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minne...
Official source for DeRoyal LAMINECTOMY SPINAL FUSION PACK, REF 89-9105.10 Nov 3, 2022 FDA device enforcement
XXX
Class II Reported ongoing
Distribution: US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minne...
Official source for DeRoyal TOTAL HIP PACK, REF 89-9113.06 Nov 3, 2022 FDA device enforcement
XXX
Class II Reported ongoing
Distribution: US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minne...
Official source for DeRoyal TOTAL HIP PACK, REF 89-9113.07 Nov 3, 2022 FDA device enforcement
XXX
Class II Reported ongoing
Distribution: US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minne...
Official source for DeRoyal BASIC EYE PACK, REF 89-9233.08 Nov 3, 2022 FDA device enforcement
XXX
Class II Reported ongoing
Distribution: US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minne...
Official source for DeRoyal MAJOR ORTHO PACK, REF 89-9250.07 Nov 3, 2022 FDA device enforcement
XXX
Class II Reported ongoing
Distribution: US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minne...
Official source for DeRoyal FOOT PACK, REF 89-9252.06 Nov 3, 2022 FDA device enforcement
XXX
Class II Reported ongoing
Distribution: US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minne...
Official source for DeRoyal FOOT PACK, REF 89-9252.07