Device Recall Reamers Orthopedic manual surgical instrument

  • Model / Serial
    Part #: PI-0507, Lot #s:1308811A, 1457704A; Part #: PI-0508, Lot #s: 1308812A, 1457705A; Part #: PI-0509, Lot #s: 1038813A, 1457706A; Part #: PI-0510, Lot #s: 1308814A, 1457707A; Part #: PI-0511, Lot #s: 1308815A, 1457708A; Part #: PI-0512, Lot #s: 1308816A, 1457709A; Part #: PI-0513, Lot #s: 1308817A, 1457710A; Part #: PI-0514, Lot #s: 1308818A, 1457711A; Part #: PI-0507-S, Lot #: 2130005; Part #: PI-0508-S, Lot #: 2130006; Part #: PI-0509-S, Lot #: 2130007; Part #: PI-0510-S, Lot #: 2130008; Part #: PI-0511-S, Lot #: 2130009; Part #: PI-0512-S, Lot #: 2130010; Part #: PI-0513-S, Lot #:2130011; Part #: PI-0514-S, Lot #: 2130012
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    GA, IN, FL, UT, AZ, CA, and NY
  • Product Description
    Captiva's lumbar intervertebral fusion system Reamers (color code rings on the Reamers).
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Captiva Spine, Inc, 967 Alternate A1A, Suite1, Jupiter FL 33477
  • Manufacturer Parent Company (2017)
  • Source
    USFDA