Device Recall MAYFIELD Ultra 360 Base Unit

All Lot numbers of Mayfield Ultra 360 Base Units, Catalogue #'s A2009 and A2029.   Affected Lot Numbers For Catalogue No. A2009  73149, 73355, 73356, 74396, 74730, 74398, 74399, 75796, 75816, 74523, 75838, 75859, 74524, 75873, 74890, 75939, 74892, 76420, 74893, 74894, 74895, 76156, 77225, 76157, 76158, 77831, 76159, 77957, 76160, 78012, 76161, 78548, 77292, 78666, 79067, 79068, 79069, 79071, 80013, 79073, 81782, 79074, 81918, 79075, 79748, 80094, 82194, 80095, 80668, 80669, 84171, 80671, 84288, 82736, 82737, 82738, 85896, 82739, 86400, 82740, 82741, 82742, 84732, 84733, 84734, 84735, 85693, 86817, 86818, 86819, 86820, 86821, 86822, 89453, 89455, 89456, 89457, 92296, 92297, 92298, 92299, 92300, 92301, 94653, 94654, 94655, 99798, 98558, 98559, 98560, 98561, 98562, 94658, 103127, 103128, 103129, 103130, 103131, 104890, 114978, 115809, E19251, 123051  Affected Lot Numbers For Catalogue No. A2029 84180, 84487, 85519, 85815, 85631, 84887, 84888, 86533, 86534, 84889, 86828, 86829, 89302, 86830, 86831, 86832, 86833, 86834, 89534, 89535, 89536, 89537, 89538, and 94167.

General and Plastic Surgery Devices

1

No

Worldwide Distribution - US Nationwide in the states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, WY, and DC. (25 government consignees) and in the foreign countries: CANADA, ALGERIA, ARAB EMIRATES, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CHILE, CHINA, COLUMBIA, CYPRESS, DENMARK, DOMINICAN REPUBLIC, FRANCE, GERMANY, GREAT BRITAN, HONG KONG, HUNGARY, INDIA, INDONESIA, ISRAEL, ITALY, JAPAN , JORDAN, KOREA, LIBYA, MACEDONIA, MAYLASIA, MEXICO, NETHERLANDS, POLAND, PORTUGAL, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SRI LANKA, TAIWAN, THAILAND, and TURKEY.

The MAYFIELD¿ Ultra 360 Base Unit for head positioner, one unit per package. || Product Usage: || This product provides the ability to position and hold a patient head while the patient is in the prone, supine, lateral or park-bench and sitting positions. It is intended to be used during diagnostic examinations or surgical procedures where a rigid support between the surgical table and a headrest or skull clamp is necessary and positional freedom is required.