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Zimmer Trabecular Metal Technology, Inc. recalls NexGenTrabecular Metal Tibial Half Block Augment, Right Lateral/Left Medial, Size 4 5MM Thickness W/Screws Item Number
Recalled March 20, 2019 · FDA recall Z-1005-2019 · Zimmer Trabecular Metal Technology
Hazard
Potentially comingled, resulting in the product in the box potentially not matching the product on the label · FDA Class II
Units
24 units
Sold at
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
Description
Potentially comingled, resulting in the product in the box potentially not matching the product on the label
Product
NexGenTrabecular Metal Tibial Half Block Augment, Right Lateral/Left Medial, Size 4 5MM Thickness W/Screws Item Number: 00544800426 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.
Manufacturer(s)
Zimmer Trabecular Metal Technology, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →