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DeRoyal CATARACT PACK (DeRoyal) – Manufacturing issue (2022)

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FDANov 3, 2022AL, AZ, CT +20 more• DeRoyal Industries Inc

DeRoyal Biopsy Pack (DeRoyal) – Unspecified Issue (2022)

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FDANov 3, 2022AL, AZ, CT +20 more• DeRoyal Industries Inc

VADER Pedicle System Torque Wrench (Icotec) – Torque Function Issue (2022)

During internal testing (at manufacturer site) of two torque wrench devices, it was detected that the torque limiting function was out of specification. The specified torque limiting value is 12 Nm. The measuring results for both instruments were 4 Nm.

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DeRoyal CATARACT PACK (DeRoyal) – Manufacturing issue (2022)

DeRoyal Biopsy Pack (DeRoyal) – Unspecified Issue (2022)

VADER Pedicle System Torque Wrench (Icotec) – Torque Function Issue (2022)

DeRoyal Total Shoulder Pack (DeRoyal) – Unspecified Issue (2022)

DeRoyal Neuro Pack (DeRoyal) – Unspecified Issue (2022)

DeRoyal Heart Pack (DeRoyal) – Steri Drapes Concern (2022)

DeRoyal ENDOVENOUS PACK (DeRoyal) – Steri Drapes issue (2022)

DeRoyal BASIC NEURO PACK (DeRoyal) – Manufacturing issue (2022)

DeRoyal BASIC PACK (DeRoyal) – Manufacturing issue (2022)

DeRoyal TOTAL KNEE PACK (DeRoyal) – Manufacturing issue (2022)

DeRoyal CATARACT PACK (DeRoyal) – Steri Drapes issue (2022)

GEO-MED LOWER EXTERMITY PACK (DeRoyal) – Steri Drapes issue (2022)

DeRoyal TRACECART POSTEROR LAMI MICRODISC (DeRoyal) – Manufacturing issue (2022)

DeRoyal BASIC EYE PACK (DeRoyal) – Manufacturing issue (2022)

DeRoyal BIOPSY PACK (DeRoyal) – Manufacturing issue (2022)

DeRoyal CRANI PACK (DeRoyal) – Manufacturing issue (2022)

DeRoyal MINOR ORAL / ENT PACK (DeRoyal) – Steri Drapes issue (2022)

DeRoyal CRANI PACK (DeRoyal) – Manufacturing issue (2022)

DeRoyal SHOULDER KIT (DeRoyal) – Manufacturing issue (2022)

DeRoyal PAIN TRAY (DeRoyal) – Manufacturing issue (2022)