FDA-Device2020-07-15Class II
3COR DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.
TeDan Surgical Innovations LLC
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
1935 screws (packaged into 387 boxes) - [5 screws per box]
Manufactured in
12615 W Airport Blvd Ste 200, Sugar Land, TX, United States
Products
3COR DISTRACTION SCREW, 14 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-2525-2020Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief