Device Recall Stelkast Crossover Acetabular Shell and Liner Hip System

  • Model / Serial
    Part Numbers SC3458-52, lot number 28820-112612; SC3474-52, lot number 28822-101812; SC3459-52, lot number 28823-101812; and SC3460-52, lot number 28821-000.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution including the states of NV, OK and PA.
  • Product Description
    Stelkast Cross-over Acetabular Shell and Liner Hip System, Part Numbers SC3458-52, SC3474-52, SC3459-52, and SC3460-52. || Intended for use in reconstruction of the articulating surface of the acetabular portion of the hip.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Stelkast Co, 200 Hidden Valley Rd, Mcmurray PA 15317-2659
  • Manufacturer Parent Company (2017)
  • Source
    USFDA