GENESIS II Tibial Base Plate (2020-07-17)

Starting date:

July 17, 2020

Posting date:

August 14, 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-73687

Last updated: 2020-08-14

• Reason
• Affected products

Affected Products

GENESIS II Tibial Base Plate

Reason

Smith & Nephew, Inc. has initiated a field action to voluntarily remove multiple lots of GENESIS II Tibial Base Plates due to an inconsistency in the raw material process. A review of the raw material manufacturing process identified that specific lots may contain units with internal non-homogenous material defects.

Affected products