Medtronic Sofamor Danek USA Inc: Medtronic Grafton Putty: a) DBM S43101 GRAFTON 0.5CC PUTTY, REF S43101; b) DBM S43102 GRAFTON 1CC PUTTY, REF S43102; c) DBM S43103 GRAFTON 2.5CC PUTTY, REF S43103; 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: 186889 units Lot/code info: a) DBM S43101 GRAFTON 0.5CC PUTTY, REF S43101, GTIN 00613994960900, Serial Numbers: A43107, A44312, A44898, A45026, A47094, A48070, A48239, A48726, A54374; b) DBM S43102 GRAFTON 1CC PUTTY, REF S43102, GTIN 00613994960894, Serial Numbers: A39801, A40711, A42973, A43546, A44572, A44970, A45136, A45543, A46181, A46352, A46538, A46924, A47103, A47710, A48122, A48391, A50563, A50858, A51802, A52414, A53427, A54070, A54689, A54892; c) DBM S43103 GRAFTON 2.5CC PUTTY, REF S43103, GTIN 00613994960887, Serial Numbers: A39091, A40452, A41163, A41376, A42289, A43008, A43345, A43555, A45523, A45714, A45746, A46289, A47357, A48134, A48230, A50024, A50343, A51014, A53131, A53706, A54060; d) DBM S43105 GRAFTON 5CC PUTTY, REF S43105, GTIN 00613994961136, Serial Numbers: A39669, A41187, A41545, A42539, A42923, A43450, A43481, A43500, A43516, A43853, A43932, A43934, A44475, A44665, A44733, A44805, A44986, A45039, A45175, A45282, A45457, A45552, A45556, A45919, A47043, A47390, A47714, A47833, A47885, A48125, A48540, A48816, A49460, A49472, A50596, A51281, A53513, A53897, A54184, A54492, A54615, A54771, A54892, A54982; e) DBM S43110 GRAFTON 10CC PUTTY, REF S43110, GTIN 00613994961129, Serial Numbers: A41514, A41616, A42444, A43082, A43201, A43235, A43608, A43805, A43852, A43925, A43955, A44054, A44267, A45150, A45454, A45474, A45680, A46359, A46622, A47260, A47287, A47525, A48070, A48080, A48092, A48565, A49050, A49411, A49520, A49924, A52108, A52214, A52379, A53417, A53518, A54052, A54164, A5417

UPC codes

00613994960900, 00613994960894, 00613994960887, 00613994961136, 00613994961129, 00643169123106

Source

Official record: FDA (Device enforcement) ↗

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