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Zimmer Trabecular Metal Technology, Inc. recalls NexGen TRABECULAR METAL FEMORAL AUGMENT BLOCK DISTAL ONLY, 20 MM Augment, Size D, Sterile, Rx Only. Product Usage: I
Recalled April 1, 2015 · FDA recall Z-1325-2015 · Zimmer Trabecular Metal Technology
Hazard
One unit of the 20 mm augments was mislabeled as 5 mm and it was subsequently distributed. · FDA Class II
Units
1 unit
Sold at
US Distribution in the state of CA
Description
One unit of the 20 mm augments was mislabeled as 5 mm and it was subsequently distributed.
Product
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.
Manufacturer(s)
Zimmer Trabecular Metal Technology, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →