Zimmer Trabecular Metal Technology, Inc.: Medical Device Recall in 2015 - (Recall #: Z-1325-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: February 4, 2015

Date Posted: April 1, 2015

Recall Number: Z-1325-2015

Event ID: 70605

Reason for Recall:

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

Status: Terminated

Product Quantity: 1 unit

Code Information:

20 MM - Part No. 00-5490-034-24, Lot #613574282T 5 MM - Part No. 00549003410, Lot #61357484T

Distribution Pattern:

US Distribution in the state of CA

Voluntary or Mandated:

Voluntary: Firm initiated