Health product recall

Phantom CS Quick Start Distraction Screw 14mm (2020-06-04)

Starting date:
June 4, 2020
Posting date:
June 19, 2020
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-73375

Last updated: 2020-06-19

Affected Products

Phantom CS Quick Start Distraction Screw 14mm

Reason

A review of complaint history and distribution records specific to TSI's distraction screws  revealed two (2) complaints by customers (outside of Canada) that the product pouch was not sealed, potentially exposing the product to non-sterile conditions. An unsealed pouch situation could present a risk of infection to patients.

Affected products

Phantom CS Quick Start Distraction Screw 14mm

Lot or serial number
  • 2018071601
Model or catalog number
  • DS-0024
Companies
Manufacturer

TeDan Surgical Innovations LLC

12615 W Airport Blvd, Suite 200

Sugar Land

77478

Texas

UNITED STATES