FDA-Device2020-07-15Class II
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.
Hazard
Lack of pouch seal. Product is labelled as sterile.
Sold states
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.
Affected count
730 screws (packaged into 146 boxes) - [5 screws per box]
Manufactured in
12615 W Airport Blvd Ste 200, Sugar Land, TX, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2528-2020Don't want to check this manually?
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