FDA-Device2024-02-14Class II
HRIS ACET CUP CUT TIP 26X140 Part Number: 6210-5-100. single-use, sterile surgical instruments used during hip arthroplasty
Howmedica Osteonics Corp.
Hazard
Failed to meet the acceptance criteria for the seal integrity and/or package integrity testing for the Sterile Barrier Outer Pouch and the Protective Barrier Inner Pouch, compromising product sterility
Sold states
Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Brazil, Canada, Chile, China (Hong Kong), Columbia, Italy, Japan, Malaysia, Netherlands (Venlo), Slovenia, S. Africa, Spain, Sweden, Switzerland, Thailand, United Kingdom.
Manufactured in
325 Corporate Dr, Mahwah, NJ, United States
Products
HRIS ACET CUP CUT TIP 26X140 Part Number: 6210-5-100. single-use, sterile surgical instruments used during hip arthroplasty
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0999-2024Don't want to check this manually?
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