Health product recall

Sterile Distraction Screws (2019-02-20)

Starting date:
February 20, 2019
Posting date:
March 8, 2019
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-69240

Affected Products

Sterile Distraction Screws

Reason

This medical device is sterile. However, the product packaging for some lots may be damaged, potentially exposing the product to non-sterile conditions. This situation presents a risk of infection to patients. No adverse events have been reported.

Affected products

Sterile Distraction Screws

Lot or serial number
  • 2017111301
  • 2018022801
  • 2018031401
  • 2018050801
Model or catalog number
  • DS-0022
  • DS-0024
Companies
Manufacturer

TeDan Surgical Innovations LLC

12615 W Airport Blvd, Suite 200

Sugar Land

77478

Texas

UNITED STATES