T2 Proximal Humeral Nail System - Long Nail (2018-06-15)

Starting date:

June 15, 2018

Posting date:

August 17, 2018

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-67376

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  Reason
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  Affected products

Affected products

T2 Proximal Humeral Nail System - Long Nail

Reason

The manufacturer has determined that products have left the factory where the quality of the sealed seam of the sterile packaging did not correspond to the specification. During the sealing process, a tyvek lid stuck to the sealing plate. The subsequently packaged products were sealed with the lid sticking to the seal plate.

Though testing of the sealed seam confirmed that the integrity of the sterile barrier is intact, integrity of the sterile barrier cannot be assured over 5 years shelf life.

Affected products