—#126273

Product

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.

FDA product code: ERL — Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Device class: Class 2
Medical specialty: Ear, Nose, Throat
510(k) numbers: K011381
Affected lot / code info: P/N 5290-628-000, Lot #13280CG2

Why it was recalled

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.

Root cause (FDA determination)

Employee error

Action the firm took

Stryker Instruments sent an Recall Notification dated March 18, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed if you have further distributed this product, please forward this letter and the attached Business Reply Form (BRF)to all affected locations. Please indicate each location on the BRF. A FedEx shipping label will be emailed to each account upon receipt of the signed Business Reply Form. This label will allow the account to return the product to be destroyed. A Business Reply Form will be included in each mailing. Return of this form will serve as confirmation that the account has received the notification and executed the recall. Follow up phone calls, emails, and faxes will be sent to non-responding accounts as necessary. Product destruction will be handled at Stryker Instruments, Kalamazoo. Labeling will be defaced and the Aggressive Blades will be disposed of in the trash compactor. For questions regarding this recall please contact Stryker Instruments: Monday-Friday 8am-5pm (EST) 269-389-2921

Recalling firm

Firm: Stryker Instruments Div. of Stryker Corporation
Address: 4100 E Milham Ave, Portage, Michigan 49002-9704

Distribution

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

Timeline

Recall initiated: 2014-03-18
Posted by FDA: 2014-03-20
Terminated: 2014-05-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #126273. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.