Home / Recalls / Medical Devices
Integra Lifesciences Sales Llc recalls Ascension¿ Silicone PIP-Silicone PIP Sz 1, Model Number: SPIP5201WW - Product Usage: The Ascension Silicone PIP impla
Recalled December 25, 2019 · FDA recall Z-0691-2020 · Integra Lifesciences Sales
Hazard
Silicone PIP Implant mislabeled as a size 1 implant on the outer packaging when in fact the package contained a size 0 implant · FDA Class II
Units
9 units
Sold at
US Nationwide distribution in the state of CA.
Description
Silicone PIP Implant mislabeled as a size 1 implant on the outer packaging when in fact the package contained a size 0 implant
Product
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.
Manufacturer(s)
Integra Lifesciences Sales Llc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →