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Medtronic MIDAS REX Legend High Speed Pneumatic System… recallZ-1067-05 · Medtronic Powered Surgical Solutions · initiated Jun 29, 2005

Terminated All recalls posted in August 2005

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Medtronic Powered Surgical Solutions or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Complaints of finger control component breaking off and falling into open surgical wound.

FDA root cause category: Other

What the company is doing

The firm initiated the recall via letter on July 1, 2005.

Recall details

Recall number
Z-1067-05
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Jun 29, 2005
Posted by the FDA
Aug 3, 2005
Recalling firm
Medtronic Powered Surgical Solutions
Quantity
191 motors
Product code
HBB
FDA submissions
K020069
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 description

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.

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

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

Other devices under the same FDA submission

109 devices cleared under K020069 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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