Reported Apr 29, 2015 · Terminated
Captiva's lumbar intervertebral fusion system Reamers (color code rings on the Reamers).
Captiva Spine, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Captiva Spine, Inc · 967 Alternate A1A · Jupiter, FL · 33477
Is this the product you have?
- Captiva's lumbar intervertebral fusion system Reamers (color code rings on the Reamers).
- Lot codes and dates
16 of 16 products
Products covered by this recall Model / number Product as published — PI-0507, Lot #s:1308811A, 1457704A PI-0508Lot #s: 1308812A, 1457705A PI-0509Lot #s: 1038813A, 1457706A PI-0510Lot #s: 1308814A, 1457707A PI-0511Lot #s: 1308815A, 1457708A PI-0512Lot #s: 1308816A, 1457709A PI-0513Lot #s: 1308817A, 1457710A PI-0514Lot #s: 1308818A, 1457711A PI-0507-SLot #: 2130005 PI-0508-SLot #: 2130006 PI-0509-SLot #: 2130007 PI-0510-SLot #: 2130008 PI-0511-SLot #: 2130009 PI-0512-SLot #: 2130010 PI-0513-SLot #:2130011 PI-0514-SLot #: 2130012 - Amount recalled
- 233 devices
Where it was sold
Why it was recalled
It is possible for the titanium color-coded ring to detach from the Reamers.
This product could cause temporary or reversible health problems — stop using it.
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