Recall Z-1480-2015— Captiva Spine, Inc
Class II · Terminated
Class II FDA medical device recall by Captiva Spine, Inc, initiated 2015-02-25, terminated 2015-06-01. FDA's recall record names no specific 510(k) clearance for this event. Product: Captiva's lumbar intervertebral fusion system Reamers (color code rings on the Reamers).. Reason: It is possible for the titanium color-coded ring to detach from the Reamers..
- Recalling firm
- Captiva Spine, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-02-25
- Terminated
- 2015-06-01
- Firm location
- Jupiter, FL, United States
Product description
Captiva's lumbar intervertebral fusion system Reamers (color code rings on the Reamers).
Reason for recall
It is possible for the titanium color-coded ring to detach from the Reamers.
Data sourced from openFDA. This site is unofficial and independent of the FDA.