FDAFDA · Food and drugs·Recall number Z-1247-2014
2.5MM Aggressive Blade Known as a Sinuscopic Shaver Blade, this device is composed of a metal cutter and plastic drive shaft that goes into a metal housing supported by a plastic hub. ENT Precision Cutter, Aggressive, ESSxlHUMMER 4, Rx Only It is used for ENT procedures and functions by means of rotation when adapted to a handpiece and console. Through the rotation, the necessary tissue is resected as required by the user. The blade housing has an etching line guide that starts with a straight line and along with a scale from 1cm to 7cm in 1cm increments that serves the doctor as a guide by indicating how far the device is being introduced into the surgical area.
Published March 26, 2014 · Recall initiated: March 18, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Stryker Instruments is voluntarily recalling the single use 2.5MM Aggressive Blade because the line on the affected part (P/N 5290-928-000, Lot #13280CG2) was a straight line without a number scale or logo. The line required for this part number includes a number scale that goes from 1cm 7cm.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Stryker Instruments Div. of Stryker Corporation
- Distributor
- US Distribution including the states of NV, CA, WA, TN, OR, SD, ID, IN and CO., and Internationally to Malaysia
- Lot
- P/N 5290-628-000, Lot #13280CG2
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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