FDA-Device2015-04-29Class II

Captiva's lumbar intervertebral fusion system Reamers (color code rings on the Reamers).

Captiva Spine, Inc
Hazard

It is possible for the titanium color-coded ring to detach from the Reamers.

Sold states
GA, IN, FL, UT, AZ, CA, and NY
Affected count
233 devices
Manufactured in
967 Alternate A1A, Suite1, Jupiter, FL, United States
Products
Captiva's lumbar intervertebral fusion system Reamers (color code rings on the Reamers).

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1480-2015

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