Integra LifeSciences Corp. (NeuroSciences): CODMAN Disposable Perforator, 14mm. Cranial perforator.

Hazard

Inadequate weld that can potentially cause the product to disassemble.

Details from the source

Reason for recall: Inadequate weld that can potentially cause the product to disassemble. Distribution: Worldwide distribution - US Nationwide including Puerto Rico and the countries of Argentina, Australia, Austria, Bahamas, Barbados, Belgium, Brazil, Canada, Chile, Colombia, Cyprus, Czechia, Dominican Republic, Ecuador, El Salvador, France, French Guiana, Germany, Ghana, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Jordan, Kenya, Korea (the Republic of), Lebanon, Lithuania, Malaysia, M Quantity: 170,510 units Lot/code info: Model No. 261221; UDI 10381780513599; Lot No. Lot Number, 5580821, 5664307, 6347547, 6566289, 6589889, 6715286, 6715287, 6756578, 6756631, 6757665, 6899419, 6910166, 7008982, 7008995, 7009033, 7009035, 7009166, 7009167, 7092837, 7093002, 7124525, 7195332, 7195376, 7195380, 7230293, 7230295, 7230296, 7230430, 7230431, 7230437, 7230439, 7230440, 7230441, 7230442, 7230443, 7230444, 7230445, 7230446, 7230447, 7230448, 7230449, 7230450, 7230451, 7230452, 7230453, 7230454, 7230455, 7230456, 7230457, 7230458, 7230459, 7230460, 7230461, 7230462, 7230463, 7230464, 7230465, 7230466, 7230467, 7230468, 7230471, 7230472, 7230473, 7230474, 7230475, 7230476, 7230477, 7230478, 7230479, 7230480, 7230481, 7230482, 7230483, 7230484, 7230485, 7230486, 7230487, 7230488, 7230489, 7230490, 7230491, 7230492, 7230493, 7230494, 7230495, 7230496, 7230497, 7230498, 7230499, 7230500, 7230501, 7230502, 7230503, 7230504, 7230505, 7230506, 7230507, 7230508, 7230509, 7230510, 7230511, 7230512, 7230513, 7230514, 7230515, 7230516, 7230517, 7230518, 7230519, 7230523, 7230524, 7230525, 7230526, 7230527, 7230528, 7230529, 7230530, 7230531, 7230532, 7230533, 7230534, 7230535, 7230536, 7230537, 7230538, 7230539, 7230540, 7230541, 7230542, 7230543, 7230544, 7230545, 7230546, 7230547, 7230548, 7230549, 7230550, 7230551, 7230552, 7230553, 7230554, 7230555, 7230556, 7230557, 7230558, 7230559, 7230560, 7230561, 7230562, 7230563, 7230564, 7230565, 7230566, 7230567, 7230568, 7230569, 7230570, 7230571, 7230572, 7230573, 72

UPC codes

10381780513599

Source

Official record: FDA (Device enforcement) ↗

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