Zimmer Trabecular Metal Technology, Inc. recalls NexGenTrabecular Metal Tibial Half Block Augment, Left Lateral/Right Medial, Size 4 5MM Thickness W/Screws Item Number:…

Recall date

February 1, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1006-2019

FDA classification

Class II

Brand / firm

Zimmer Trabecular Metal Technology, Inc.

Sold / distributed

Worldwide Distribution - US Nationwide Distribution in the states of AL, CA, CO, ID, MS,NE, NJ, NY, OH, OR, PA, TX, VA, WI and Foreign CANADA, JAPAN, GERMANY , NETHERLANDS

Why it was recalled

Potentially comingled, resulting in the product in the box potentially not matching the product on the label

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

NexGenTrabecular Metal Tibial Half Block Augment, Left Lateral/Right Medial, Size 4 5MM Thickness W/Screws Item Number: 00544800436 Product Usage: The Trabecular Metal Tibial Cone Augments are intended for use where severe degeneration, trauma, or other pathology of the knee joint indicates total knee arthroplasty. When used with the NexGen Complete Knee Solution Rotating Hinge Knee (RHK) System, the Trabecular Metal Tibial Cone Augments are for cemented use only. When used with the NexGen Complete Knee Solution Legacy Constrained Condylar Knee System, the Trabecular Metal Tibial Cone Augments are for cementless or cemented use.