The MAYFIELD Ultra 360 Base Unit for head positioner, one unit per package. Product Usage: This product provides the abi

FDA device recall Z-1084-2015 · posted 2015-02-10 · Terminated

Recall details

Recalling firm

Integra LifeSciences Corporation

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.

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

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

FWZ

Quantity affected

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,

Date initiated

2014-12-19

Date posted

2015-02-10

Date terminated

2017-02-22

Location

Cincinnati, OH