Z-1480-2015 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- April 29, 2015
- Initiation Date
- February 25, 2015
- Termination Date
- June 1, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 233 devices
Product Description
Captiva's lumbar intervertebral fusion system Reamers (color code rings on the Reamers).
Reason for Recall
It is possible for the titanium color-coded ring to detach from the Reamers.
Distribution Pattern
GA, IN, FL, UT, AZ, CA, and NY
Code Information
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