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.
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device · product 1 of 1
Zimmer Title 2 Bone Screw Remover Instrument, Part Number ET1093-01 Rx Only, Non-Sterile. The Screw Remover is a component of the Endius TITLE 2 Polyaxial Spinal System, used for posterior lumbar fusion procedures.
Possibility of the weld to the quick-connect breaking when force is applied to the handle for pedicle screw removal. A broken weld could lead to the use of an alternate method of screw removal, which could delay surgery up to 30 minutes.
These labels are deterministic app interpretations, not FDA categories.
Possibility of the weld to the quick-connect breaking when force is applied to the handle for pedicle screw removal. A broken weld could lead to the use of an alternate method of screw removal, which could delay surgery up to 30 minutes.
