NexGen TRABECULAR METAL FEMORAL AUGMENT BLOCK DISTAL ONLY recalled over labeling errors

Recall date

February 4, 2015

Source

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

Official notice title

Zimmer Trabecular Metal Technology, Inc. recalls NexGen TRABECULAR METAL FEMORAL AUGMENT BLOCK DISTAL ONLY, 20 MM Augment, Size D, Sterile, Rx Only. Product Usage: Inte…

Recall number

Z-1325-2015

FDA classification

Class II

Brand / firm

Zimmer Trabecular Metal Technology, Inc.

Sold / distributed

US Distribution in the state of CA

Why it was recalled

One unit of the 20 mm augments was mislabeled as 5 mm and it was subsequently distributed.

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

What was recalled

NexGen TRABECULAR METAL FEMORAL AUGMENT BLOCK DISTAL ONLY, 20 MM Augment, Size D, Sterile, Rx Only. Product Usage: 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 Augments are for cemented use only. When used with the NexGen Complete Knee Solution-Legacy Constrained Condylar Knee System, the Trabecular Metal Augments are for cementless or cemented use.