Medtronic Sofamor Danek USA Inc: Medtronic Grafton DBF: a) PUTTY T50101 GRAFTON DBF 1CC, REF T50101; b) PUTTY T50101INT GRAFTON DBF 1CC, REF T50101INT; c) PUTTY T50103 GRAFTON DBF 3CC, REF T50103; d)

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: 47436 units Lot/code info: a) PUTTY T50101 GRAFTON DBF 1CC, REF T50101, GTIN 00643169656017, Serial Numbers: A40005-036, A40005-037, A40005-038, A40005-039, A40005-040, A40005-041, A40005-042, A40005-043, A40005-045, A40005-046, A40005-047, A40005-048, A40005-049, A40005-051, A40005-053, A40005-054, A40005-055, A40005-056, A40005-057, A40005-058, A40005-059, A40005-060, A40005-061, A40005-062, A40005-063, A40005-064, A40005-065, A40005-066, A40005-067, A40005-068, A40005-069, A40005-070, A40005-071, A40005-072, A40005-073, A40005-074, A40005-075, A40005-076, A40005-077, A40005-078, A40005-079, A40005-080, A40005-081, A40005-082, A40005-083, A40005-084, A40005-085, A40005-086, A40005-087, A40005-088, A40005-089, A40005-090, A40005-091, A40005-092, A40005-093, A40005-094, A40005-095, A40005-096, A40005-097, A40005-098, A40005-099, A40005-100, A40005-101, A40005-102, A40304-210, A40304-211, A40304-212, A40304-213, A40304-214, A40304-215, A40304-216, A40304-217, A40304-218, A40304-219, A40304-220, A40304-221, A40304-222, A40304-223, A40304-224, A40304-225, A40304-226, A40304-227, A40304-228, A40304-229, A40304-230, A40304-231, A40304-232, A40304-233, A40304-234, A40304-235, A40304-236, A40304-237, A40304-238, A40304-239, A40304-240, A40304-241, A40304-242, A40304-243, A40304-244, A40304-245, A40304-246, A40304-247, A40304-248, A40304-249, A40304-250, A40304-251, A40304-252, A40304-253, A40304-254, A40304-255, A40304-256, A40304-258, A40304-259, A40304-260, A40304-261, A40304-262, A40304-263, A40304-264, A4

UPC codes

00643169656017

Source

Official record: FDA (Device enforcement) ↗

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