CLASS II Device recall · Reported 29 Apr 2015 · FDA Enforcement Report
Captiva's lumbar intervertebral fusion system Reamers (color recalled
Captiva Spine is recalling Captiva's lumbar intervertebral fusion system Reamers (color code rings on the Reamers), distributed in 7 states. The recall was initiated on 25 Feb 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1480-2015
- FDA event ID
- 70710
- Recalling firm
- Captiva Spine, Jupiter, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Feb 2015
- FDA classified
- 21 Apr 2015
- Reported
- 29 Apr 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Spinal Implants
Timeline
| 25 Feb 2015 | Recall initiated by company | |
| 21 Apr 2015 | Classified by FDA | +55 days |
| 29 Apr 2015 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
It is possible for the titanium color-coded ring to detach from the Reamers.
Product as listed by the FDA
Captiva's lumbar intervertebral fusion system Reamers (color code rings on the Reamers).
Where it was distributed
GA, IN, FL, UT, AZ, CA, and NY
Questions about this recall
Why was it recalled?
It is possible for the titanium color-coded ring to detach from the Reamers.
Which lots 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
Where was it sold?
GA, IN, FL, UT, AZ, CA, and NY
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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