Integra LifeSciences Corporation: Medical Device Recall in 2015 - (Recall #: Z-1084-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: December 19, 2014

Date Posted: February 18, 2015

Recall Number: Z-1084-2015

Event ID: 70088

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.

Status: Terminated

Product Quantity: 1053 Units

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.

Voluntary or Mandated:

Voluntary: Firm initiated