Medtronic Sofamor Danek USA Inc: Medtronic Grafton DBF Inject: a) GRAFTON T50303 DBF INJECT 3CC, REF T50303; b) GRAFTON T50306 DBF INJECT 6CC, REF T50306; c) GRAFTON T50309 DBF INJECT 9CC, REF T50309;

Hazard

Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier.

Details from the source

Reason for recall: Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier. Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Brunei Darussalam, Canada, Chile, Colombia, Denmark, Dominican Republic, Ecuador, Finland, Ghana, Greece, Guatemala, Hong Kong, India, Ireland, Israel, Jamaica, Japan, Jordan, Korea, Republic Of, Kuwait, Lebanon, Liechtenstein, Luxembourg, Macao, Malaysia, Mexico, Mongolia, Namibia, Netherlands, New Zealand, Norway, Om Quantity: 10037 units Lot/code info: a) GRAFTON T50303 DBF INJECT 3CC, REF T50303, GTIN 00763000254001, Serial Numbers: A44493-011, A44493-012, A44493-013, A44493-014, A44493-015, A44493-016, A44493-017, A44493-018, A44493-019, A44493-020, A44493-021, A44493-022, A44493-023, A44493-025, A44493-028, A44591-011, A44591-012, A44591-013, A44591-014, A44591-015, A44591-016, A44591-017, A44591-018, A44591-019, A44591-020, A44591-021, A44591-022, A44591-023, A44591-024, A44591-025, A44591-026, A44591-027, A44591-028, A44591-029, A44591-030, A44591-031, A44591-032, A44591-033, A44591-034, A44591-035, A44591-036, A44591-037, A44591-039, A44591-041, A44591-042, A44591-043, A44591-044, A44591-045, A44591-046, A44591-047, A44591-048, A44591-049, A44591-050, A44591-051, A44591-052, A44591-053, A44591-054, A44591-055, A44591-056, A44591-057, A44591-058, A44591-059, A44591-060, A44591-061, A44591-062, A44591-064, A44591-065, A44591-066, A44591-067, A44591-068, A44591-069, A44591-070, A44591-071, A44591-072, A44591-073, A44591-074, A46056-011, A46056-014, A46056-017, A46056-018, A46056-019, A46056-020, A46056-021, A46056-022, A46056-023, A46056-024, A46056-025, A46056-026, A46056-028, A46056-029, A46056-030, A46056-031, A46056-032, A46056-033, A46056-034, A46056-035, A46056-036, A46056-037, A46056-038, A46056-039, A46056-040, A46056-041, A46056-042, A46056-043, A46056-044, A46056-045, A46056-046, A46056-047, A46056-048, A46056-049, A46056-050, A46345-021, A46345-022, A46345-023, A46345-024, A46345-025, A46345-026, A46345-027, A

UPC codes

00763000254001, 00763000254018

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.