Medtronic Sofamor Danek USA Inc: Medtronic Accelerate Grafton DBF a) ACCELERATE BG SET T50203 GRAFTON DBF 3CC, REF T50203; b) ACCELERATE BG SET T50206 GRAFTON DBF 6CC, REF T50206; c) ACCELERATE BG SET

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: 3037 units Lot/code info: a) ACCELERATE BG SET T50203 GRAFTON DBF 3CC, REF T50203, GTIN 00763000244705, Serial Numbers: A45206-011, A45206-012, A45206-013, A45206-014, A45206-016, A45206-018, A45206-019, A45206-020, A45206-021, A45206-022, A45206-023, A45206-024, A45206-025, A45206-026, A45206-027, A45206-028, A45206-029, A45206-030, A45206-031, A45206-032, A45206-033, A45206-034, A45206-035, A45206-036, A45206-037, A45206-038, A45206-040, A45206-041, A45206-042, A45206-043, A45206-045, A45206-046, A45206-047, A45206-048, A45206-049, A45206-050, A45206-051, A45206-052, A45206-053, A45206-054, A45206-055, A45206-056, A45206-057, A45206-058, A45206-061, A45206-063, A45206-064, A45206-066, A45206-067, A45206-068, A45206-069, A45206-070, A45206-071, A45206-072, A45489-011, A45489-012, A45489-015, A45489-016, A45489-017, A45489-021, A45489-022, A45489-023, A45489-024, A45489-025, A45489-026, A45489-027, A45489-028, A45489-030, A45489-032, A45489-036, A45489-037, A45489-038, A45489-039, A45489-040, A45489-041, A45489-042, A45489-045, A45489-046, A45489-047, A45489-048, A45489-049, A45489-050, A45489-051, A45870-011, A45870-012, A45870-013, A45870-014, A45870-015, A45870-016, A45870-017, A45870-018, A45870-019, A45870-020, A45870-021, A45870-022, A45870-023, A45870-025, A45870-026, A45870-027, A45870-032, A45870-033, A45870-036, A45870-038, A45870-039, A45870-040, A45870-041, A45870-042, A45870-043, A45870-044, A45870-045, A45870-046, A45870-047, A46716-036, A46716-037, A46716-038, A46716-039, A46716-040, A4

UPC codes

00763000244705, 00763000244712, 00763000244729, 00763000244736

Source

Official record: FDA (Device enforcement) ↗

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