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

Recalled July 15, 2020 · FDA recall Z-2526-2020 · TeDan Surgical Innovations

Hazard

Lack of pouch seal. Product is labelled as sterile. · FDA Class II

Units

1965 screws (packaged into 393 boxes) - [5 screws per box]

Sold at

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.

Description

Lack of pouch seal. Product is labelled as sterile.

Product

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

Manufacturer(s)

TeDan Surgical Innovations LLC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →