Reported Dec 25, 2019 · Terminated
Ascension¿ Silicone PIP-Silicone PIP Sz 1, Model Number: SPIP5201WW - Product Usage: The Ascension Silicone PIP implant…
Integra Lifesciences Sales LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Integra Lifesciences Sales Llc · 311 Enterprise Dr · Plainsboro, NJ · 08536-3344
Is this the product you have?
- Ascension¿ Silicone PIP-Silicone PIP Sz 1
- Model NumberSPIP5201WW -
- Product UsageThe 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
- Lot codes and dates
- Lot NumberLot 192715T
- Amount recalled
- 9 units
Where it was sold
- Nationwide
- 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
This product could cause temporary or reversible health problems — stop using it.
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