TeDan Surgical Innovations LLC: Medical Device Recall in 2020 - (Recall #: Z-2528-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: May 15, 2020

Date Posted: July 15, 2020

Recall Number: Z-2528-2020

Event ID: 85830

Reason for Recall:

Lack of pouch seal. Product is labelled as sterile.

Status: Terminated

Product Quantity: 730 screws (packaged into 146 boxes) - [5 screws per box]

Code Information:

Product Code: DS-0022 UDI Number: 00851797006474 Lot Number: 2018062901

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated