FDAFDA · Alimentos y medicamentos·N.º oficial Z-0554-2015
Traction tong replacement screws, non-springloaded are used in traction skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and are sold under the CareFusion, Boss Instruments, and Stealth Surgical brand names.
Publicado el 17 de diciembre de 2014 · Inicio del retiro: 8 de septiembre de 2014
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The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Instrumed International, Inc.
- Distribuidor
- Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.
- Lote
- 1) Instrumed Product Name: Replacement Screw Non-Springloaded, Traction Tong; Instrumed Product Number: 638-05429; Trade Name: CareFusion; CareFusion Product Name: Gardner-Wells Titanium Fixation Screw Non-Springloaded; CareFusion Item Number: NL9514-T; Lot Number: 100512. 2) Instrumed Product Name: Replacement Screw Non-Springloaded, Traction Tong; Instrumed Product Number: 638-05429; Trade Name: Boss Instruments; Boss Instruments Product Name: Replacement Screw Non-Springloaded, Traction Tong; Boss Instruments Item Number: 74-0185T; Lot Numbers: 020512, 100512, 110211. 3) Instrumed Product Name: Replacement Screw Non-Springloaded, Traction Tong; Instrumed Product Number: 638-05429; Trade Name: Stealth Surgical; Stealth Surgical Product Name: Replacement Screw Non-Springloaded, Traction Tong; Stealth Surgical Item Number: SS2193BT; Lot Numbers: 070312. 4) Instrumed Product Name: Replacement Screw Non-Springloaded, Traction Tong; Instrumed Product Number: 638-05429; Trade Name: CareFusion; CareFusion Product Name: Replacement Screw Non-Springloaded, Traction Tong; CareFusion Item Number: VM85-12965; Lot Numbers: 100512, 110211.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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