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