openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
device · product 1 of 1
Captiva's lumbar intervertebral fusion system Reamers (color code rings on the Reamers).
It is possible for the titanium color-coded ring to detach from the Reamers.
Code information
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