Recall Z-1084-2015
Integra LifeSciences Corporation · initiated December 19, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: 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.
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.
FDA-determined cause: Nonconforming Material/Component
Action taken
Integra sent an Urgent - Voluntary Medical Device Recall letter dated December 19, 2014 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to take the following actions: 1. Review your MAYFIELD equipment and determine if you have any MAYFIELD Ultra 360 Base Units 2. Once identified we recommend that you discontinue use and remove them from service until they are repaired by an authorized Integra Repair Center 3. Complete the attached Recall Acknowledgement and Repair Form 4. Upon receipt of the Recall Acknowledgement and Repair Form, Customer Service will contact you and provide an RMA number and instructions for returning the productor questions call 609-936-6822. For questions contact Customer Service: USA 800-654-2873 Outside USA 609-936-5400
Details
- Recall number
- Z-1084-2015
- Initiated
- December 19, 2014
- Posted by FDA
- February 10, 2015
- Terminated
- February 22, 2017
- Product code
- FWZ – Operating Room Accessories Table Tray
- Quantity
- 1053 Units
- Distribution
- 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…
- Recalling firm
- Integra LifeSciences Corporation, Cincinnati, OH