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

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  Reason
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  Affected products

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