Stryker Instruments Div. of Stryker Corporation: Medical Device Recall in 2014 - (Recall #: Z-1247-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: March 18, 2014

Date Posted: March 26, 2014

Recall Number: Z-1247-2014

Event ID: 67775

Reason for Recall:

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.

Status: Terminated

Product Quantity: 90 units

Code Information:

P/N 5290-628-000, Lot #13280CG2

Distribution Pattern:

US Distribution including the states of NV, CA, WA, TN, OR, SD, ID, IN and CO., and Internationally to Malaysia

Voluntary or Mandated:

Voluntary: Firm initiated