FDAFDA · Alimentos y medicamentos·N.º oficial Z-1504-2020
D-0014 3COR 14MM DISTRACTION SCREWS, 5/BOX, STERILE - Product Usage: The 3COR Distraction Screws and the TSI Quick Start Distraction Screws products are intended for the distraction in the anterior approach to the cervical spine from C2 thru C7. The products are to be used by trained surgeons and are designed for use with TSI distractors and screwdrivers.
Publicado el 25 de marzo de 2020 · Inicio del retiro: 18 de febrero de 2019
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
The items identified for recall are labeled as sterile. However, the manufacturer has found that product packaging for the lots listed above may be damaged, potentially exposing the product to non sterile conditions. This situation presents a risk of infection to patients.
Qué hacer
Voluntary: Firm initiated · E-Mail
Detalles del retiro
- Fabricante
- TeDan Surgical Innovations LLC
- Distribuidor
- Worldwide.
- Lote
- Item #: D-0014 2018050201
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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