FDA recall Z-2530-2020

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.

Reason for recall

Lack of pouch seal. Product is labelled as sterile.

Distribution

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.

Key facts

Status

Terminated

Initiation date

2020-05-15

Report date

2020-07-15

Termination date

2022-09-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Sugar Land, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2530-2020