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