Captiva's lumbar intervertebral fusion system Reamers — Class II medical device recall Z-1480-2015
Terminated recall by Captiva Spine, Inc, reported 2015-04-29, distributed in AZ, CA, FL, GA, IN, NY, UT. It is possible for the titanium color-coded ring to detach from the Reamers.
| Recall number | Z-1480-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Captiva Spine, Inc, Jupiter, FL, United States |
| Recall initiated | 2015-02-25 |
| Classified | 2015-04-21 |
| Reported by FDA | 2015-04-29 |
| Terminated | 2015-06-01 |
| Distributed | AZ, CA, FL, GA, IN, NY, UT |
| Quantity | 233 devices |
| Reason classes | device malfunction |
| Lot numbers | 1038813A, 1308812A, 1308814A, 1308815A, 1308816A, 1308817A, 1308818A, 1457704A, 1457705A, 1457706A, 1457707A, 1457708A, 1457709A, 1457710A, 1457711A, 2130005, 2130006, 2130007, 2130008, 2130009, 2130010, 2130011, 2130012 |
| Model numbers | PI-0507, PI-0507-S, PI-0508, PI-0508-S, PI-0509, PI-0509-S, PI-0510, PI-0510-S, PI-0511, PI-0511-S, PI-0512, PI-0512-S, PI-0513, PI-0513-S, PI-0514, PI-0514-S |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1480-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.