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Recall Observatory FDA recall evidence

Device product

Scooter

Z-1505-2021

April 01, 2021

Class II

Product summary

Firm
Merits Holdings Co. dba Merits Health Products, Inc.
Event
Event 87673
Status
Ongoing
Classification
Class II
Quantity
189 units
Official record key
device-enforcement:Z-1505-2021

Official wording

Reason: Seat baseplate pin has broken in the field.

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

Distribution pattern: Distributed 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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Seat baseplate pin has broken in the field.