TeDan Surgical Innovations LLC: Medical Device Recall in 2020 - (Recall #: Z-1506-2020)

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:

DS-0024 QUICK START DISTRACTION SCREW 14MM 5/BOX STERILE - Product Usage: These products are intended to be used by trained surgeons and are designed for use with TSI distractors and screwdrivers.

Product Classification:

Class II

Date Initiated: February 18, 2019

Date Posted: March 25, 2020

Recall Number: Z-1506-2020

Event ID: 84252

Reason for Recall:

The items identified for recall are labeled as sterile. However, the manufacturer has found that product packaging for the lots listed above may be damaged, potentially exposing the product to non sterile conditions. This situation presents a risk of infection to patients.

Status: Terminated

Product Quantity: Total=146 boxes (48 boxes for Lot 2018022801 and 98 boxes for Lot 2018050801)

Code Information:

Item #: DS-0024 Lot #s: 2018022801 2018050801

Distribution Pattern:

Worldwide.

Voluntary or Mandated:

Voluntary: Firm initiated