Stryker Instruments Div. of Stryker Corporation: Medical Device Recall in 2016 - (Recall #: Z-0874-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

8450-009-040 4.0MM 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.

Product Classification:

Class II

Date Initiated: November 30, 2016

Date Posted: December 28, 2016

Recall Number: Z-0874-2017

Event ID: 75819

Reason for Recall:

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

Status: Terminated

Product Quantity: 1,257 in total

Code Information:

Lot Number:16029017, Product Number: 8450-009-040

Distribution Pattern:

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).

Voluntary or Mandated:

Voluntary: Firm initiated