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U.S. Department of Health and Human Services

Class 2 Device Recall Legend

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 Class 2 Device Recall Legendsee related information
Date Initiated by FirmJune 29, 2005
Date PostedAugust 03, 2005
Recall Status1 Terminated 3 on September 24, 2007
Recall NumberZ-1067-05
Recall Event ID 32560
510(K)NumberK020069 
Product Classification Motor, Drill, Pneumatic - Product Code HBB
ProductMedtronic 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.
Code Information 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
Recalling Firm/
Manufacturer		 Medtronic Powered Surgical Solutions
4620 N Beach St
Fort Worth TX 76137-3219
Manufacturer Reason
for Recall		Complaints of finger control component breaking off and falling into open surgical wound.
FDA Determined
Cause 2		Other
ActionThe firm initiated the recall via letter on July 1, 2005.
Quantity in Commerce191 motors
DistributionNationwide. 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = HBB
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