Z-3073-2024 Class II Ongoing
FDA device recall Z-3073-2024 was initiated by Medtronic Neuromodulation on June 17, 2024 and is designated Class II. Reason for recall: A subset of the handsets within the kit may not be able to complete the pairing process with the communicator upon initial setup. The recall status is ongoing. Affected quantity: 211 devices.
Recall Details
- Product Type
- Devices
- Report Date
- September 18, 2024
- Initiation Date
- June 17, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 211 devices
Product Description
Medtronic Handset with Communicator, Model TH90Q01, InterStim Smart Programmer and Communicator Kits, containing the Model HH90 Handset and the TM90 Communicator.
Reason for Recall
A subset of the handsets within the kit may not be able to complete the pairing process with the communicator upon initial setup.
Distribution Pattern
US Nationwide distribution.
Code Information
GTIN 0076300092754, serial numbers: NPV0082351, NPV0085575, NPV0082308, NPV0082309, NPV0082314, NPV0082328, NPV0082329, NPV0082349, NPV0082412, NPV0082483, NPV0082494, NPV0082608, NPV0082631, NPV0082646, NPV0082684, NPV0082689, NPV0082690, NPV0082691, NPV0082756, NPV0082866, NPV0082869, NPV0082899, NPV0082921, NPV0083001, NPV0083071, NPV0083084, NPV0083116, NPV0083125, NPV0083171, NPV0083507, NPV0083577, NPV0083629, NPV0083632, NPV0083853, NPV0083883, NPV0083917, NPV0083944, NPV0083948, NPV0083954, NPV0083972, NPV0084077, NPV0084084, NPV0084104, NPV0084113, NPV0084119, NPV0084125, NPV0084177, NPV0084211, NPV0084253, NPV0084283, NPV0084293, NPV0084295, NPV0084304, NPV0084305, NPV0084311, NPV0084312, NPV0084313, NPV0084317, NPV0084330, NPV0084340, NPV0084353, NPV0084355, NPV0084428, NPV0084473, NPV0084523, NPV0084610, NPV0084634, NPV0084679, NPV0084681, NPV0084695, NPV0084697, NPV0084751, NPV0084753, NPV0084754, NPV0084767, NPV0085004, NPV0085034, NPV0085036, NPV0085057, NPV0085059, NPV0085077, NPV0085081, NPV0085473, NPV0085510, NPV0085529, NPV0085580, NPV0085601, NPV0085616, NPV0085626, NPV0085631, NPV0085647, NPV0085653, NPV0082276, NPV0082278, NPV0082281, NPV0082304, NPV0082313, NPV0082316, NPV0082320, NPV0082340, NPV0082352, NPV0082358, NPV0082376, NPV0082377, NPV0082418, NPV0082421, NPV0082431, NPV0082450, NPV0082451, NPV0082476, NPV0082480, NPV0082508, NPV0082513, NPV0082514, NPV0082520, NPV0082524, NPV0082537, NPV0082539, NPV0082543, NPV0082559, NPV0082562, NPV0082569, NPV0082571, NPV0082572, NPV0082591, NPV0082635, NPV0082666, NPV0082674, NPV0082695, NPV0082701, NPV0082722, NPV0082723, NPV0082740, NPV0082769, NPV0082779, NPV0082782, NPV0082789, NPV0082806, NPV0082859, NPV0082871, NPV0082879, NPV0082882, NPV0082897, NPV0082913, NPV0082915, NPV0082916, NPV0082923, NPV0082928, NPV0082931, NPV0082944, NPV0082945, NPV0082949, NPV0082952, NPV0082960, NPV0082963, NPV0083005, NPV0083027, NPV0083036, NPV0083047, NPV0083052, NPV0083053, NPV0083104, NPV0083129, NPV0083134, NPV0083175, NPV0083178, NPV0083189, NPV0083192, NPV0083200, NPV0083225, NPV0083228, NPV0083229, NPV0083230, NPV0083237, NPV0083277, NPV0083289, NPV0083302, NPV0083312, NPV0083329, NPV0083332, NPV0083344, NPV0083345, NPV0083349, NPV0083371, NPV0083396, NPV0083484, NPV0083506, NPV0083522, NPV0083526, NPV0083555, NPV0083575, NPV0083596, NPV0083604, NPV0083613, NPV0083618, NPV0083646, NPV0083649, NPV0083688, NPV0083708, NPV0083712, NPV0083716, NPV0083729, NPV0083738, NPV0083827, NPV0083842, NPV0083845, NPV0083846, NPV0083847, NPV0083859, NPV0083937, NPV0084126.