Integra Lifesciences recalls Ascension Silicone PIP implants mislabeled as size 1 when actually size 0. This labeling error may cause incorrect implant placement. Consumers should contact the manufacturer for details.
Silicone PIP Implant mislabeled as a size 1 implant on the outer packaging when in fact the package contained a size 0 implant
Integra Lifesciences is recalling Ascension Silicone PIP implants that were mislabeled as size 1 when they actually contain a size 0 implant. This error could lead to improper surgical placement if the wrong size is used during procedures.
The implant package was mislabeled as a size 1 when it actually contained a size 0 implant. This labeling error could lead to incorrect surgical placement if the wrong size is used during procedures. However, the recall does not indicate immediate harm to patients.
Patients who received the Ascension Silicone PIP implant (model SPIP5201WW) from Integra Lifesciences are affected. Surgeons and medical staff who used these implants during procedures are most at risk.
Check for the model number SPIP5201WW on the packaging. The product was sold with lot number 192715T. This recall applies to implants used for cementless replacement of the proximal interphalangeal joint.
Reach out to Integra Lifesciences for specific guidance on the recalled product.
The recall is for a labeling error that could lead to incorrect implant placement, but the record does not mention immediate harm to patients.
Contact Integra Lifesciences directly for details about the recalled product.
Check for the model number SPIP5201WW and lot number 192715T on the packaging.
We’ve drafted a message you can send Integra Lifesciences to request your refund or repair — edit it as you like.
Subject: Recall Z-0691-2020 — Integra Lifesciences Integra Lifesciences Hello, I own a Integra Lifesciences that is covered by recall Z-0691-2020 from Integra Lifesciences. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
