Device Recall Turon

  • Model / Serial
    Lot numbers: 53987943, 53987944, 53987945, 53987946, and 53987947.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution -- Including states of TX, FL, and GA.
  • Product Description
    Turon Revision Glenoid Poly Liner. || The Metal Backed Revision Glenoid is a two piece metal backed polyethylene glenoid component for use in total shoulder arthroplasty. It includes a metal baseplate and polyethylene liner. || DJO Surgical shoulder devices are intended for treatment of patients who are candidates for shoulder arthroplasty per the indications for use.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Encore Medical, Lp, 9800 Metric Blvd, Austin TX 78758
  • Source
    USFDA

5 devices with a similar name

Learn more about the data here

  • Model / Serial
    101521L01, 115670L18, 128092L10, 136172L07, 136172L08, 141511L22, 37369L10A, 37369L10B, 37837L23A, 37837L23B, 37837L23C, 37837L23D, 51103L05E, 51103L05F, 52748L02A, 52748L02B, 52748L02C, 52748L02D, 52748L02E, 52748L02F, 52748L02G, 52748L02H, 57074L05A, 89910L10
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US, South Korea, Australia, Canada, United Kingdom/Ireland, Germany
  • Product Description
    Turon Impaction Fixture
  • Manufacturer
  • Model / Serial
    Part numbers: 804-05-021, 804-05-022, 804-05-023, 804-05-024, 804-05-025, 804-05-026, 804-05-027, 804-05-028, 804-05-029, 804-05-030, 804-05-031, 804-05-032, 804-05-033, 804-05-034,  804-05-035, 804-05-036, 804-05-037, 804-05-038, 804-05-039, 804-05-040, 804-05-041, 804-05-042, 804-05-043, 804-05-044, 804-05-045
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    TX, FL, SC, GA
  • Product Description
    Turon Shoulder System Instrumentation, Turon Humeral Head Trials, DJO Surgical
  • Manufacturer
  • Model / Serial
    Part number 804-15-000, and 804-15-001
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    TX, FL, SC, GA
  • Product Description
    Turon Shoulder System Instrumentation, Turon Trial Humeral Neck, DJO Surgical
  • Manufacturer
  • Model / Serial
    Part number 804-25-006, 804-25-007, 804-25-008, 804-25-009, 804-25-010
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    TX, FL, SC, GA
  • Product Description
    Turon Shoulder System Instrumentation, Turon Trial Pegged Glenoid, DJO Surgical
  • Manufacturer
  • Model / Serial
    Part number 804-25-024, and 804-25-025
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    TX, FL, SC, GA
  • Product Description
    Turon Shoulder System Instrumentation, Turon Pegged Glenoid Drill Guide, REF 804-25-024, DJO Surgical
  • Manufacturer