(VEPTR) VERTICAL EXPANDABLE PROSTHETIC TITANIUM RIB CAUDAL RIB SUPPORTS (2015-08-04)

Starting date:

August 4, 2015

Posting date:

August 24, 2015

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-54774

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  Reason
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  Affected products

Affected Products

A. (VEPTR) VERTICAL EXPANDABLE PROSTHETIC TITANIUM RIB CAUDAL RIB SUPPORTS

Reason

This recall is being initiated because the last hole on the VEPTR Caudal Rib Supports, subject to this recall, may be partially formed. Fully lengthening the construct to the partially formed last hole may result in mechanical failure of the construct due to extension bar breakage, which could require unplanned surgical intervention to exchange components. In addition to the risks inherent to re-operation, potential effects on the patient could also include pain, loss of deformity correction, and/or soft tissue/visceral injury.

Affected products