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
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
