FDAClass IIMarch 26, 2014

2.5MM Aggressive Blade Known as a Sinuscopic Shaver recall

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…

Why was 2.5MM Aggressive Blade Known as a Sinuscopic Shaver 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

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…
Recalling firm
Stryker Instruments Div. of Stryker Corporation
Quantity
90 units
Distribution
US Distribution including the states of NV, CA, WA, TN, OR, SD, ID, IN and CO., and Internationally to Malaysia
Recall date
March 26, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
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