medical Class II Updated 2019-12-25

Integra Lifesciences Sales Llc recalls Ascension¿ Silicone PIP-Silicone PIP Sz 1, Model Number: SPI

Recalled 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.

Hazard / Issue

Silicone PIP Implant mislabeled as a size 1 implant on the outer packaging when in fact the package contained a size 0 implant

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot Number: Lot 192715T
View official government recall

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