FDAFDA · Alimentos y medicamentos·N.º oficial Z-2160-2017
Hoffmann LRF Safety Clip (Bone Transport Strut), 14 x 12 x 5 mm, REF 4933-0-401, NDC (01)07613327131475(10)V07241 Product Usage: Intended for fixation of fractures, joint contractures, fusions, limb lengthening, deformity correction, and bone and soft tissue reconstruction in pediatric patients and adults.
Publicado el 31 de mayo de 2017 · Inicio del retiro: 26 de abril de 2017
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
Stryker is recalling Hoffmann LRF (Limb Reconstruction Frame) System Safety Clip - Bone Transport Strut because there is a potential for loosening of the safety clips from the intended position on the Quick Release mechanism of the Transport Struts.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Stryker Howmedica Osteonics Corp.
- Distribuidor
- US Nationwide distribution in the states of CA, FL, MD and VT
- Lote
- Lot Numbers: J49236, V07241, V30655, V47575 and V49404
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States