device · product 1 of 1
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.
- Recall number
- Z-1084-2015
- Initiated
- December 19, 2014
- Classification
- Class II
- Status
- Terminated
- Recalling firm
- Integra LifeSciences Corporation
- Quantity
- 1053 Units
App-derived interpretation
Through an investigation of complaints, Integra found that there is the possibility for the locking handle mechanism of the Base Units to fail during use.
Official device-enrichment evidence · Sourced
Nonconforming Material/Component
Inspect official wording and provenance
Reason for recall
Through an investigation of complaints, Integra found that there is the possibility for the locking handle mechanism of the Base Units to fail during use.
Code information
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.
Distribution pattern
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.