Recall Z-1084-2015 ยท FWZ Operating Room Accessories Table Tray
Integra LifeSciences Corporation
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 s
| Date | Feb 10, 2015 (initiated Dec 19, 2014) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| Action | 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 a |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.