medical Class II Updated 2019-03-20

Zimmer Trabecular Metal Technology, Inc. recalls NexGenTrabecular Metal Tibial Half Block Augment, Right Late

Recalled 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.


Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot Numbers: 63253751 63257915 63291542 UDI: (01) 00889024307858 (17) 210228 (10) 63253751 (01) 00889024307858 (17) 210228 (10) 63257915 (01) 00889024307858 (17) 210430 (10) 63291542
View official government recall

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