Medtronic Sofamor Danek USA Inc: Medtronic Grafton Plus Paste a) DBM S45001 GRAFTON 1CC PASTE, REF S45001; b) DBM S45005 GRAFTON 5CC PASTE, REF S45005; c) DBM S45010 GRAFTON 10CC PASTE, REF S45010; 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: 37721 units Lot/code info: a) DBM S45001 GRAFTON 1CC PASTE, REF S45001, GTIN 00613994961037, Serial Numbers: A46006, A40308, A42539, A43901, A44220, A45597, A45671, A46339, A48873, A51546, A52593, A52757, A53414; b) DBM S45005 GRAFTON 5CC PASTE, REF S45005, GTIN 00613994961020, Serial Numbers: A40309, A43891, A45123, A45614, A46395, A46625, A46708, A48098, A48545, A48646, A48920, A49642, A50256, A51481, A51591, A52422, A52947, A53416, A53534, A53685, A53927, A54681; c) DBM S45010 GRAFTON 10CC PASTE, REF S45010, GTIN 00613994961013, Serial Numbers: A48673, A40169, A41945, A42622, A42931, A43105, A43124, A43340, A43904, A44606, A45676, A46344, A46456, A46730, A47917, A48147, A48149, A48275, A48980, A49864, A50243, A51016, A51041, A51755, A52183, A52329, A52709, A52713, A52954, A53755, A53944, A54258, A54365, A54784, A54804, A54988; d) DBM T45001 1CC PASTE GRAFTON PLUS, REF T45001, GTIN 00643169122949, Serial Numbers: A24679-156, A24679-157, A24679-158, A24679-159, A24679-160, A24679-161, A24679-162, A24679-163, A24679-164, A24679-165, A24679-166, A24679-167, A24679-168, A24679-169, A24679-170, A24679-171, A24679-172, A24679-173, A24679-176, A24679-177, A24679-178, A24679-179, A24679-180, A24679-181, A24679-182, A24679-183, A24679-184, A24679-185, A24679-186, A24679-187, A24679-188, A24679-189, A24679-190, A24679-191, A24679-192, A24679-193, A24679-194, A24679-195, A24679-196, A24679-197, A24679-198, A24679-199, A24679-200, A24679-201, A24679-202, A24679-203, A24679-204, A24679-205, A24679-206, A24679-207

UPC codes

00613994961037, 00613994961020, 00613994961013, 00643169122949

Source

Official record: FDA (Device enforcement) ↗

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