Captiva's lumbar intervertebral fusion system Reamers recall
Captiva's lumbar intervertebral fusion system Reamers (color code rings on the Reamers).
Why was Captiva's lumbar intervertebral fusion system Reamers recalled?
It is possible for the titanium color-coded ring to detach from the Reamers.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Captiva's lumbar intervertebral fusion system Reamers (color code rings on the Reamers).
- Recalling firm
- Captiva Spine, Inc
- Quantity
- 233 devices
- Distribution
- GA, IN, FL, UT, AZ, CA, and NY
- Recall date
- April 29, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)