Z-1247-2014Class II

2.5MM Aggressive Blade Known as a Sinuscopic Shaver Blade, this device is composed of a metal cutter and...

Name: Z-1247-2014 2.5MM Aggressive Blade Known as a Sinuscopic Shaver Blade, this device is composed of a metal cutter and...
Creator: Stryker Instruments Div. of Stryker Corporation
Published: 2014-03-18
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2014-03-18 / Terminated / root cause: manufacturing process

FDA source

Stryker Instruments Div. of Stryker Corporation began a recall of 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... on 2014-03-18. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1247-2014
Classification: Class II
Status: Terminated
Initiated: 2014-03-18
Posted: 2014-03-20
Terminated: 2014-05-15
Recalling firm: Stryker Corp.
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.
Product code: ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
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.
Root cause tag: manufacturing process
FDA root 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
Product codes and lots: P/N 5290-628-000, Lot #13280CG2

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1247-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1247-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-26	2014-03-20

Product code ERL

K011381Class IIHummer IV Microdebrider SystemStryker Instruments / cleared 2001-05-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)