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
Synthes 3.0 MM TI Cannulated Screw Instrument and Implant Set
A screw set was returned from the field for destruction after being exposed to flood water, which was erroneously reprocessed and returned to the field. Initial investigative testing indicated the components within the set may be cytotoxic.
These labels are deterministic app interpretations, not FDA categories.
A screw set was returned from the field for destruction after being exposed to flood water, which was erroneously reprocessed and returned to the field. Initial investigative testing indicated the components within the set may be cytotoxic.
Code information
Part Number: 145.17E Lot Number: EV01609, individual part numbers contained within 145.17E: 304.49 309.501 310.221 310.804 311.43 312.151 312.153 313.969 314.463 314.464 314.465 319.291 319.292 319.702 319.97 398.408 398.409 402.608-402.640 402.714-402.740 419.89 419.972 292.622, and 292.623.
