Device Recall Power Drill Torque Limiter

  • Modelo / Serial
    Power Drill Torque Limiter: Product Code 99-93568; Lot (Exp Date) V1388296 (12/28/2019), V1388432 (12/29/2019), V1389857 (01/13/2020), V1400707 (05/18/2020), V1400940 (05/23/2020), V1410027 (09/01/2020); UDI: 18054242512318.   Galaxy UNYCO Diaphyseal Tibia Sterile Kit: Product Code 99-93506; Lot (Exp Date) V1389818 (01/12/2020), V1389819 (01/12/2020), V1389886 (02/13/2020), V1399881 (05/10/2020), V1400800 (05/22/2020), V1402023 (06/03/2020), V1405602 (07/17/2020), V1406422 (07/26/2020), V1410082 (09/02/2020), R1412578 (09/28/2020), V1414451 (10/19/2020), V1421785 (02/01/2021), V1425406 (03/13/2021), B1012462 (06/19/2021), B1012776 (06/26/2021), B1019431 (07/05/2021), B1031608 (08/05/2021), B1052165 (10/23/2021), B1049195 (10/25/2021), B1080028 (02/16/2022), B1099157 (04/08/2022), B1107271 (04/09/2022); UDI: 18054242512325.   Galaxy UNYCO Mini Kit Instruments Sterile: Product Code 99-93509; Lot (Exp Date) V1408711 (08/01/2020), V1410026 (09/01/2020), V1422854 (02/14/2021), V1427350 (04/09/2021), V1429217 (04/26/2021), B1083360 (02/20/2022); UDI: 18054242513629.   Galaxy UNYCO Diaphyseal Femur Box: Product Code 99-93790; Lot (Exp Date) B1019281 (04/09/2021); UDI: 1805424515159.   Galaxy UNYCO Knee Bridging Box: Product Code 99-93791; Lot (Exp Date) B1019282 (04/09/2021); UDI: 18054242515166.  Galaxy UNYCO Ankle Bridging Box - Unilateral Frame; Product Code 99-93792; Lot (Exp Date) V140597 (03/21/2020); UDI: 18054242513643.   Galaxy UNYCO Ankle Bridging Box - Delta Frame: Product Code 99-93793; Lot (Exp Date) V1409944 (03/09/2020); UDI: 18054242513650.   Galaxy UNYCO Diaphyseal Tibia Box: Product Code 99-93794; Lot (Exp Date) V1410194 (04/18/2020). UDI: 18054242513667.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution -- US, including the states of CA, FL, & PA; and, the countries of Australia, Germany, Finland, France, Italy, Lithuania, Netherlands, Singapore, South Africa, Sweden, Switzerland, & United Kingdom.
  • Descripción del producto
    Orthofix Power Drill Torque Limiter, Sterile, Rx Only, Single Use; Sold individually and in the Galaxy UNYCO Diaphyseal Tibia Sterile Kit, Galaxy UNYCO Mini Kit Instruments Sterile, Galaxy UNYCO Diaphyseal Femur Box, Galaxy UNYCO Knee Bridging Box, Galaxy UNYCO Ankle Bridging Box - Unilateral Frame, Galaxy UNYCO Ankle Bridging Box - Delta Frame, and Galaxy UNYCO Diaphyseal Tibia Box. || Intended to be used for temporary bone stabilization in trauma and orthopedic procedures of the lower limb prior to definitive treatment.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Orthofix Srl, Via Delle Nazioni 9, Bussolengo Italy
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA