Terminated

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.

FDA Recall Z-1084-2015 · Posted 2015-02-10

Recalling FirmIntegra LifeSciences Corporation

Recall StatusTerminated

Product CodeFWZ

Date Initiated2014-12-19

Date Terminated2017-02-22

Product Quantity1053 Units

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.

Firm 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 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

Root Cause

Nonconforming Material/Component

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.