Reported Dec 28, 2016 · Terminated

8450-009-030 3.0MM Precision Round, 13CM, single use, Sterile The Stryker MIS (Minimally Invasive Surgery) product…

Stryker Instruments Div. of Stryker Corporation

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Stryker Instruments Div. of Stryker Corporation · 4100 E Milham Ave · Portage, MI · 49002-9704

8450-009-030 3.0MM Precision Round, 13CM, single use, Sterile The Stryker MIS (Minimally Invasive Surgery) product offering, is used to remove osseous material during surgical cases
Each cutting accessory consists of" A shank (B) with a notch (A), that fits in the attachment on one end and is connected to the head of the bur on the other end. " A head (C) connected to the shank (B) and removes material using machined flutes. The head is machined directly on the shank/neck of the bur

The agency filed one notice per product. You are reading one of them; the other 6 are below.

Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because the burs may exhibit signs of corrosion.

This product could cause temporary or reversible health problems — stop using it.

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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47 in total.