FOOTPRINT Ultra PK Suture Anchor,4.5mm; 5.5mm (2020-03-19)

Starting date:

March 19, 2020

Posting date:

April 17, 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-72801

Last updated: 2020-04-17

• Reason
• Affected products

Affected Products

FOOTPRINT Ultra PK Suture Anchor,4.5mm; 5.5mm

Reason

Smith &Amp; Nephew, Inc., has initiated a voluntary recall to remove specific lots of the FOOTPRINT Ultra PK Suture Anchor due to a packaging design related issue. The space between the device and the packaging permits excessive movement, which could potentially lead to the displacement of the anchor's tip protector allowing the tip of the anchor to create a sterile breach.

Affected products