Captiva Spine, Inc recalls Captiva's lumbar intervertebral fusion system Reamers (color code rings on the Reamers).
- Recall date
- February 25, 2015
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1480-2015
- FDA classification
- Class II
- Brand / firm
- Captiva Spine, Inc
- Sold / distributed
- GA, IN, FL, UT, AZ, CA, and NY
Why it was recalled
It is possible for the titanium color-coded ring to detach from the Reamers.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Captiva's lumbar intervertebral fusion system Reamers (color code rings on the Reamers).
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