This is an accessory to Intelect Advanced, Intelect Mobile, Intelect Neo, and V-Sonic devices. NYLATEX WRAP - Product Us

FDA device recall Z-2590-2020 · posted 2020-07-13 · Terminated

Recall details

Recalling firm

DJO, LLC

Reason for recall

The device accessories were not labeled with appropriate latex warning.

Action taken

The firm's initial notification was sent to consignees on June 25, 2018. On August 14, 2020 the firm sent an additional "Urgent: Safety Alert" email to affected customers. In addition to informing consignees about the recall, the firm requested consignees take the following actions: 1. if you have any of the products listed in the product list attached to the letter, please discontinue the use of that product and discard it. 2. DJO Global is recommending that, in a timely manner, you send a notification to all customers who have purchased or were issued the affected products from you. 3. Please select the Click Here to Respond button below as soon as possible to complete your response

Root cause

Process change control

Status

Terminated

Product code

IMF

Quantity affected

41,801 units

Distribution

Worldwide distribution - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, O

Date initiated

2018-06-25

Date posted

2020-07-13

Date terminated

2022-11-15

Location

Vista, CA