PlainRecalls
FDA Devices Moderate Class II Terminated

8470-009-030 3.0MM Precision Round, 16CM, 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.

Reported: December 28, 2016 Initiated: November 30, 2016 #Z-0870-2017

Product Description

8470-009-030 3.0MM Precision Round, 16CM, 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.

Reason for Recall

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

Details

Units Affected
1257 in total
Distribution
Worldwide Distribution - US (nationwide) including states of: AK, AL, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NM, NY, OH, OK, PA, SC, TN, TX, VA, WA, WI and countries of: Canada, Japan, Venlo (Netherlands), France, and UK (United Kingdom).
Location
Portage, MI

Frequently Asked Questions

What product was recalled?
8470-009-030 3.0MM Precision Round, 16CM, 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.. Recalled by Stryker Instruments Div. of Stryker Corporation. Units affected: 1257 in total.
Why was this product recalled?
Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because the burs may exhibit signs of corrosion.
Which agency issued this recall?
This recall was issued by the FDA Devices on December 28, 2016. Severity: Moderate. Recall number: Z-0870-2017.