FDA-Device2019-12-25Class II
Ascension¿ Silicone PIP-Silicone PIP Sz 1, Model Number: SPIP5201WW - Product Usage: The Ascension Silicone PIP implant is intended for cementless replacement of the proximal interphalangeal joint in patients with advanced osteoarthritis, post-traumatic arthritis and rheumatoid arthritis.
Integra Lifesciences Sales Llc
Hazard
Silicone PIP Implant mislabeled as a size 1 implant on the outer packaging when in fact the package contained a size 0 implant
Sold states
US Nationwide distribution in the state of CA.
Affected count
9 units
Manufactured in
311 Enterprise Dr, Plainsboro, NJ, United States
Products
Ascension¿ Silicone PIP-Silicone PIP Sz 1, Model Number: SPIP5201WW - Product Usage: The Ascension Silicone PIP implant is intended for cementless replacement of the proximal interphalangeal joint in patients with advanced osteoarthritis, post-traumatic arthritis and rheumatoid arthritis.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0691-2020Don't want to check this manually?
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