FDAFDA · Alimentos y medicamentos·N.º oficial Z-2220-2012
Altrx" Altralinked" Polyethylene liners Description: An acetabular liner is one of the implants used during total hip arthroplasty to replace the damaged hip joint to help increase patient mobility and to reduce pain. Packaging: Product is placed into a PETG tray, sealed with a Tyvek lid. This is placed into a second PETG tray and sealed with a Tyvek lid. This package is placed into a paperboard carton, labeled, and shrink-wrapped. Intended Use: An acetabular liner is used in combination with other implants for total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.
Publicado el 29 de agosto de 2012 · Inicio del retiro: 24 de julio de 2012
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
In the recalled lot, the products were not machined according to the production router, a size 52 cup (122136052) was machined instead. This resulted in a size 52 liner being etched and labeled as a size 54 liner.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- DePuy Orthopaedics, Inc.
- Distribuidor
- Worldwide Distribution - USA including PA and the country of Canada
- Lote
- Catalog number: 1221-36-054 and Lot Number: 231859
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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