FDAFDA · Food and drugs·Recall number Z-1480-2015
Captiva's lumbar intervertebral fusion system Reamers (color code rings on the Reamers).
Published April 29, 2015 · Recall initiated: February 25, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
It is possible for the titanium color-coded ring to detach from the Reamers.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Captiva Spine, Inc
- Distributor
- GA, IN, FL, UT, AZ, CA, and NY
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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