Ascension¿ Silicone PIP-Silicone PIP Sz 1 recalled over labeling errors
- Recall date
- November 4, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Integra Lifesciences Sales Llc recalls Ascension¿ Silicone PIP-Silicone PIP Sz 1, Model Number: SPIP5201WW - Product Usage: The Ascension Silicone PIP implant…
- Recall number
- Z-0691-2020
- FDA classification
- Class II
- Brand / firm
- Integra Lifesciences Sales Llc
- Sold / distributed
- US Nationwide distribution in the state of CA.
Why it was recalled
Silicone PIP Implant mislabeled as a size 1 implant on the outer packaging when in fact the package contained a size 0 implant
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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.
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