Stryker Instruments Div. of Stryker Corporation: Medical Device Recall in 2016 - (Recall #: Z-0868-2017)

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:

8450-107-530 3.0MM Precision Match Head, 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-0868-2017

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:16032017, Product Number: 8450-009-030

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