FDA Device

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

Hazard

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

What You Should Do

Remedy

Zimmer Trabecular Metal Technology sent an email dated 12/10/2014 to their sole customer. The customer was requested to return the affected product.

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Products

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 j
Brand
Zimmer Trabecular Metal Technology, Inc.
UPC
20 MM - Part No. 00-5490-034-24, Lot #613574282T 5 MM - Part No. 00549003410, Lot #61357484T

Units Affected

1 unit

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