Class 2 Device Recall Hummer IV Microdebrider System

• Date Initiated by Firm: March 18, 2014
• Date Posted: March 20, 2014
• Recall Status: Terminated on May 15, 2014
• Recall Number: Z-1247-2014
• Recall Event ID: 67775
• 510(K)Number: K011381
• Product Classification: Drill, surgical, ent (electric or pneumatic) including handpiece - Product Code ERL
• 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.
• Code Information: P/N 5290-628-000, Lot #13280CG2
• Recalling Firm/ Manufacturer: Stryker Instruments Div. of Stryker Corporation; 4100 E Milham Ave; Portage MI 49002-9704
• For Additional Information Contact: Kelly Jo Whipple; 269-323-7700
• Manufacturer 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.
• FDA Determined Cause: Employee error
• Action: 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
• Quantity in Commerce: 90 units
• Distribution: US Distribution including the states of NV, CA, WA, TN, OR, SD, ID, IN and CO., and Internationally to Malaysia
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = ERL and Original Applicant = STRYKER INSTRUMENTS