NexGen - TM Components (2016-04-22)

Starting date:

April 22, 2016

Posting date:

April 29, 2016

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-58168

• Reason
• Affected products

Affected Products

A. NEXGEN-TM CR TIBIAL COMPONENT
B. NEXGEN-TM LPS TIBIAL COMPONENT
C. NEXGEN-TM PRIMARY PATELLA

Reason

Zimmer Biomet is initiating a recall of specific lots of Dual Foil Pouched Sterile Trabecular Metal (TM) Implants. Studies have found that in some instances, tears/holes were present in either the inner foil pouch or the outer foil pouch, but never in both in the same sample. Affected product was distributed between May 2011 and May 2015.

Affected products