FDA-Device2015-04-01Class II
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 Augmen
Zimmer Trabecular Metal Technology, Inc.
Hazard
One unit of the 20 mm augments was mislabeled as 5 mm and it was subsequently distributed.
Sold states
US Distribution in the state of CA
Affected count
1 unit
Manufactured in
10 Pomeroy Rd, Parsippany, NJ, United States
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 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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1325-2015Don't want to check this manually?
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