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U.S. Department of Health and Human Services

Class 2 Device Recall Scooter

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 Class 2 Device Recall Scootersee related information
Date Initiated by FirmApril 01, 2021
Create DateApril 28, 2021
Recall Status1 Open3, Classified
Recall NumberZ-1505-2021
Recall Event ID 87673
510(K)NumberK011707 K011751 K011753 K142162 K952042 
Product Classification Vehicle, motorized 3-wheeled - Product Code INI
ProductScooter
Code Information Pioneer 3 Scooter - Model Number: S131; Part No: S13152ARMU; Serial Numbers: MU200900928, MU200600612, MU200600610, MU200600887, MU200600621, MU200600620, MU200600619, MU200600618, MU200600608, MU200600616, MU200600609, MU200600607, MU200600615, MU200600613, MU200900930, MU200600892, MU200600874, MU200600889, MU200600877, MU200600617, MU200600888, MU200600876, MU200600883, MU200600879, MU200600885, MU200900923, MU200600886, MU200600893, MU200600890, MU200600611, MU200600875 Pioneer 3 Scooter - Model Number: S131; Part No: S13152SBMU; Serial Numbers: MU200900944, MU200900942 Pioneer 4 Scooter - Model Number: S141; Part No: S14151ARMU; Serial Numbers: MU200900956, MU200900953 Pioneer 4 Scooter - Model Number: S141; Part No: S14152ARMU; Serial Numbers: MU200800943, MU200600346, MU200600353, MU200600357, MU200800940, MU200900961, MU200801127, MU200801132, MU200800947, MU200600360, MU200800938, MU200801131, MU200600358, MU200600359, MU200600344, MU200801134, MU200600354, MU200600356, MU200600351, MU200600345, MU200600355, MU200600348, MU200801122, MU200801128, MU200900971, MU200600347, MU200600361, MU200600352, MU200600349, MU200600350, MU200800931, MU200800951, MU200800949, MU200801121, MU200800941, MU200800939, MU200800942, MU200801133, MU200801125, MU200900970, MU200801123 Pioneer 4 Scooter - Model Number: S141; Part No: S14152SBMU; Serial Numbers: MU200800952, MU200501029, MU200500382, MU200501033, MU200500381, MU200501039, MU200500363, MU200500359, MU200801161, MU200500372, MU200801157, MU200501031, MU200500364, MU200501044, MU200501042, MU200800962, MU200500378, MU200601118, MU200601123, MU200601112, MU200601110, MU200601111, MU200800957, MU200801152, MU200800976, MU200601114, MU200601121, MU200601126, MU200800975, MU200801168, MU200901022, MU200501032, MU200501046, MU200901029, MU200901020, MU200500376, MU200501028, MU200501036, MU200501041, MU200501037, MU200501040, MU200601125, MU200601120, MU200501047, MU200501038, MU200501043, MU200501034, MU200501035, MU200501030, MU200601116, MU200601117, MU200601115, MU200901004, MU200901023, MU200901007, MU200901014, MU200901008, MU200901016, MU200901000, MU200601113, MU200500365, MU200500373, MU200500371, MU200500361, MU200500374, MU200500367, MU200800973, MU200500360 Pioneer 1 Scooter - Model Number: S235; Part No: S2354-ARMUB; Serial Numbers: MU200600053, MU200600052, MU200600051, MU200600054 Pioneer 1 Scooter - Model Number: S235; Part No: S2354-SBMUB; Serial Numbers: MU200600056, MU200600058, MU200600059 Pioneer 2 Scooter - Model Number: S245; Part No: S2454-ARMUB; Serial Numbers: MU200400958, MU200400969, MU200601135, MU200400960, MU200400967, MU200400968, MU200400965, MU200400964, MU200400966, MU200400962, MU200400963 Pioneer 2 Scooter - Model Number: S245; Part No: S2454-SBMUB; Serial Numbers: MU200400975, MU200400988, MU200400979 Pioneer 9 Scooter - Model Number: S331; Part No: S331-1ARMU; Serial Numbers: MU200801178, MU200700070, MU200700075, MU200700076, MU200700069, MU200801188 Pioneer 10 Scooter - Model Number: S341; Part No: S341-1ARMU; Serial Numbers: MU200800993, MU200800992, MU200800991, MU200800994, MU200800979, MU200800977, MU200800983, MU200800989, MU200800995, MU200800990 Silverado Extreme Scooter - Model Number: S940; Part No: S940A-SDMU; Serial Numbers: MU200800528, MU200700079, MU200800531, MU200800526, MU200800535, MU200700085, MU200700081 Silverado Scooter - Model Number: S941; Part No: S941A1SVMU; Serial Numbers: MU200800538 
Recalling Firm/
Manufacturer		 Merits Holdings Co. dba Merits Health Products, Inc.
4245 Evans Ave
Fort Myers FL 33901-9311
For Additional Information ContactHolly Allison
800-963-7487
Manufacturer Reason
for Recall		Seat baseplate pin has broken in the field.
FDA Determined
Cause 2		Process change control
ActionA Recall notification letter titled, "MEDICAL DEVICE FIELD CORRECTION" was sent to consignees on 04/07/2021 via email and by certified mail on 04/16/2021. The firm stated they made phone call notifications on 04/01/2021. The letter instructs the consignee to Contact impacted customer using a personalized customer letter (template provided). The notification can be sent by mail, email or phone. (IF by phone, please keep a log of call. Date/Time/Result); replace the old seat plate with new one provided using the SOP provided. The field correction should take approximately 15 minutes to complete.; complete and return the Service and Repair Report (sent with new part), inspect the installation and note it on the appropriate Scooter or Power Chair Inspection Record provided; use the RA shipping label (sent with new part) and return old seat plate to Merits Health Products along with the Service and Repair Report (one filled out for each unit); and when all of the units in the possession of the consignee are finished, please return the completed Inspection Report/s to Merits by mail or email.
Quantity in Commerce189 units
DistributionDistributed nationwide to AL, AK, AZ, AR, CA, CO, CT, FL, GA, ID, IL, IN, IO, KS, KY, LA, MN, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, PR, SC, TN, TX, UT, VT, VA, WA, WV, WI and internationally to Canada
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = INI
510(K)s with Product Code = INI
510(K)s with Product Code = INI
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