TeDan Surgical Innovations LLC recalls PHANTOM CS QUICK START DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in…

Recall date

May 15, 2020

Source

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

Recall number

Z-2528-2020

FDA classification

Class II

Brand / firm

TeDan Surgical Innovations LLC

Sold / distributed

Worldwide distribution - U.S. Nationwide distribution including in the states of: AZ, CA, FL, GA, HI, IL, MA, MI, NC, NH, NJ, NY, NV, PA, PR, TN, TX, and WA . The countries of Australia, Canada, France, Philippines, Taiwan, U.A.E., and United Kingdom.

Why it was recalled

Lack of pouch seal. Product is labelled as sterile.

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

What was recalled

PHANTOM CS QUICK START DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.