Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1067-05

Medtronic MIDAS REX Legend High Speed Pneumatic System, Gold Touch Motor. Manufactured by Medtronic, Inc...

Medtronic Powered Surgical Solutions / initiated 2005-06-29 / Terminated

Medtronic Powered Surgical Solutions began a recall of Medtronic MIDAS REX Legend High Speed Pneumatic System, Gold Touch Motor. Manufactured by Medtronic, Inc. Powered Surgical Solutions, 4620 North Beach Street... on . The reason FDA records is "Complaints of finger control component breaking off and falling into open surgical wound". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-1067-05
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Medtronic Powered Surgical Solutions
Product
Medtronic MIDAS REX Legend High Speed Pneumatic System, Gold Touch Motor. Manufactured by Medtronic, Inc. Powered Surgical Solutions, 4620 North Beach Street, Fort Worth, TX 76137.
Product code
HBB Motor, Drill, Pneumatic
Reason for recall
Complaints of finger control component breaking off and falling into open surgical wound.
FDA root cause
Other
Action
The firm initiated the recall via letter on July 1, 2005.
Quantity in commerce
191 motors
Distribution
Nationwide. The device was distributed to hospitals and medical facilities in AL, AR, CA, CT, DC, DE, FL, HI, IA, IL, IN, ME, MN, MT, NC, NE, NJ, NM, NY, OH, PA, SC, TN, TX, and VA. Devices were also distributed to the following foreign countries: Japan, Mexico, Netherlands, Canada, and Venezuela.
Product codes and lots
Serial #s: A0746, A2434, A2435, A2437, A2438, A3363, A3364, A3365, A3366, A3370, A3371, A3659, A3660, A3661, A3662, A3664, A3665, A3666, A3668, A4409, A4410, A4411, A4574, A4575, A4577, A4578, A4579, A4580, A4581, A4582, A4583, A4584, A4586, A4587, A4588, A4589, A4590, A4591, A4593, A5205, A5559, A5560, A5561, A5565, A5566, A5568, A5569, A5570, A5763, A5764, A5765, A5766, A5767, A5787, A5788, A5789, A5790, A5791, A5792, A5793, A5794, A5941, A5943, A5944, A5946, A5948, A5951, A5952, A5956, A5959, A6073, A6074, A6075, A6078, A6079, A6081, A6429, A6430, A6431, A6432, A7374, A7376, A7378, A7380, A7381, A7382, B0115, B0117, B0185, B0187, B0188, B0189, B0190, B0191, B0192, B0193, B0194, B0195, B0196, B0197, B0198, B0199, B0200, B0201, B0204, B0205, B0208, B0209, B0210, B0211, B0212, B0240, B0241, B0242, B1815, B1817, B1818, B1819, B1861, B1862, B1865, B1866, B1868, B1869, B1870, B1871, B1908, B1909, B1910, B1912, B1914, B1915, B1916, B1917, B1976, B1977, B1978, B2107, B2109, B2110, B2113, B2114, B2115, B2116, B2117, B2118, B2119, B2122, B2124, B2125, B2126, B2128, B2130, B2131, B2133, B2134, B2135, B2142, B2145, B2146, B2147, B2148, B2150, B2404, B2700, B2701, B2702, B2704, B2705, B2708, B2709, B2710, B2712, B2713, B2714, B2716, B2717, B2718, B2721, B2722, B2723, B2724, B2725, B2735, B3171, B3174, T1518, T2419, T5712, T6686, T9728