Stryker Instruments Div. of Stryker Corporation recalls (Stryker) AccuPlace Round Level Needle Guide; Assists the user with inserting a needle at a predetermined angle for com…

Recall date

February 4, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1038-2016

FDA classification

Class II

Brand / firm

Stryker Instruments Div. of Stryker Corporation

Sold / distributed

Nationwide Distribution-including the states of AZ, CA, CO, CT, FL, GA, IA, KS, MA, MI, MN, MO, NY, OH, OK, PA, TX, VA, WA, and WI.

Why it was recalled

During an evaluation of the product packaging, it was determined that there is a potential for the product to cause damage to the packaging, creating a possible breach in sterility.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

(Stryker) AccuPlace Round Level Needle Guide; Assists the user with inserting a needle at a predetermined angle for computer tomography.