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TeDan Surgical Innovations LLC recalls PHANTOM CS QUICK START DISTRACTION SCREW, 16 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in
Recalled July 15, 2020 · FDA recall Z-2530-2020 · TeDan Surgical Innovations
Hazard
Lack of pouch seal. Product is labelled as sterile. · FDA Class II
Units
340 screws (packaged into 68 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 QUICK START DISTRACTION SCREW, 16 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 →