Recall Z-1006-2019— Zimmer Trabecular Metal Technology, Inc.

Name: FDA recall Z-1006-2019
Creator: U.S. Food and Drug Administration
Published: 2019-02-01

Class II · Terminated

Class II FDA medical device recall by Zimmer Trabecular Metal Technology, Inc., initiated 2019-02-01, terminated 2020-05-15. It names one FDA 510(k) clearance: K024161. Product: NexGenTrabecular Metal Tibial Half Block Augment, Left Lateral/Right Medial, Size 4 5MM Thickness W/Screws Item Number: 00544800436 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.. Reason: Potentially comingled, resulting in the product in the box potentially not matching the product on the label.

Recalling firm: Zimmer Trabecular Metal Technology, Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-02-01
Terminated: 2020-05-15
Firm location: Parsippany, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K024161 — NEXGEN COMPLETE KNEE SOLUTION - TRABECULAR METAL AUGMENTSImplex Corp.·cleared 2003-01-15

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

NexGenTrabecular Metal Tibial Half Block Augment, Left Lateral/Right Medial, Size 4 5MM Thickness W/Screws Item Number: 00544800436 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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.