FDA-Device2018-03-21Class II
Accolade and Restoration hip product; Catalog Number: 6021-0030, 6276-1-127, 6276-5-216, 6020-2530, 6020-4535, 6021-0740, 6021-0230, and 6021-4535
Howmedica Osteonics Corp.
Hazard
Inner and outer sterile barriers not fully sealed.
Sold states
Distributed in ten (10) states: AR, DE, FL, IL, IN, MI, NJ, OH, TN, and TX; and Canada, Sweden, United Kingdom, France, Spain, Italy, Japan, Romania, Colombia, Netherlands, and Australia.
Affected count
255
Manufactured in
325 Corporate Dr, Mahwah, NJ, United States
Products
Accolade and Restoration hip product; Catalog Number: 6021-0030, 6276-1-127, 6276-5-216, 6020-2530, 6020-4535, 6021-0740, 6021-0230, and 6021-4535
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0941-2018Don't want to check this manually?
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