Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Ascension¿ Silicone PIP-Silicone PIP Sz 1 Recalled by Integra Lifesciences Sales Llc Due to Mislabeling
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Integra Lifesciences Sales Llc directly.
Affected 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.
Quantity: 9 units
Why Was This Recalled?
Silicone PIP Implant mislabeled as a size 1 implant on the outer packaging when in fact the package contained a size 0 implant
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Integra Lifesciences Sales Llc
Integra Lifesciences Sales Llc has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report