Integra Recalls Mislabeled Ascension Silicone PIP Joint Implants
Integra Lifesciences is recalling nine Ascension Silicone PIP implants that were mislabeled as size 1 but contained size 0 implants.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard is a labeling error (mislabeling) rather than a structural defect or contamination, which aligns with the Moderate severity criteria for minor labeling errors.
Plain-English summary
Integra Lifesciences Sales LLC is recalling nine units of the Ascension Silicone PIP implant, model number SPIP5201WW, lot 192715T. The product is intended for cementless replacement of the proximal interphalangeal joint in patients with advanced osteoarthritis, post-traumatic arthritis, and rheumatoid arthritis.
The recall was initiated because the implants were mislabeled as size 1 on the outer packaging, but the packages actually contained size 0 implants. This labeling error could result in the implantation of an incorrect size device.
The affected units were distributed nationwide in the state of California. Patients who have received this specific implant should contact their healthcare provider to discuss the labeling discrepancy and determine if any further action is necessary.
The recalled product
- 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…
- Manufacturer
- Integra Lifesciences Sales Llc
- Hazard
- Affected units
- 9
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Number: Lot 192715T
Distribution
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