Z-2590-2020 Class II Terminated
FDA device recall Z-2590-2020 was initiated by DJO, LLC on June 25, 2018 and is designated Class II. Reason for recall: The device accessories were not labeled with appropriate latex warning. The recall status is terminated (terminated November 15, 2022). Affected quantity: 41,801 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 22, 2020
- Initiation Date
- June 25, 2018
- Termination Date
- November 15, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 41,801 units
Product Description
Reason for Recall
Distribution Pattern
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, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI and WV The countries of Algeria, Armenia, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Belgium, Bolivia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Congo, Congo, The Democratic Republic of the, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, England, Estonia, Ethiopia, Finland, France, Germany, Greece, Guatemala, Hong Kong, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kenya, Korea, Republic of, Kuwait, Lebanon, Lithuania, Luxembourg, Malaysia, Malta, Mexico, Morocco, Netherlands, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, United Republic of, Thailand, Trinidad and Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Viet Nam.