TeDan Surgical Innovations LLC recalls DS-0024 QUICK START DISTRACTION SCREW 14MM 5/BOX STERILE - Product Usage: These products are intended to be used by tra…

Recall date

February 18, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1506-2020

FDA classification

Class II

Brand / firm

TeDan Surgical Innovations LLC

Sold / distributed

Worldwide.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.