FDANovember 4, 2019device
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 recall recorded by the U.S. Food & Drug Administration.
The hazard
Silicone PIP Implant mislabeled as a size 1 implant on the outer packaging when in fact the package contained a size 0 implant
What to do
FDA enforcement status: Terminated
Brands named
integra lifesciences salesintegraintegra lifesciences
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- CPSCJC Sales Recalls Lil' Buddies Pet Laser Toys Due to Risk of Serious Injury or Death from Battery Ingestion Hazard; Violates Mandatory Standard for Consumer Products with Button Cell Batteries2026-04-16
- FDACodman CerebroFlo EVD Catheter with Endexo Technology. Contains 5 sets. Product ID: 37.550.501. The CerebroFlo EVD Catheter is a 3.3 mm diameter (10 Fr.), 35 cm long polyurethane catheter for diverting cerebrospinal fluid (CSF) from the ventricles of the brain through a series of drainage holes n...2026-04-10
- FDAEdwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO2026-03-27
- FDACytal Burn Matrix 10x15 cm. Product ID: BMM1015.2026-03-19
- FDACytal Wound Matrix 2-Layer 7x10 cm. Product ID: WSM0710.2026-03-19
- FDACytal Burn Matrix 7x10 cm. Product ID: BMM0710.2026-03-19
- FDACytal Wound Matrix 2-Layer 5x5 cm. Product ID: WSM0505.2026-03-19
- FDACytal Wound Matrix 2-Layer 10x15 cm. Product ID: WSM1015.2026-03-19
Own something like this?
AllClear screens your whole list against every CPSC, FDA, USDA and NHTSA recall — and tells you the day a new one names something you own.
Start free — 200 items, no card →