The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1006-2019·Announced 2019-03-20

FDA Recalls NexGen Trabecular Metal Tibial Augments Due to Labeling Mismatch

Zimmer Trabecular Metal Technology is recalling 26 units of NexGen Trabecular Metal Tibial Half Block Augments because the product in the box may not match the label.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (implanting the wrong device) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a Class II recall for 26 units of NexGen Trabecular Metal Tibial Half Block Augments, manufactured by Zimmer Trabecular Metal Technology, Inc. The specific item number is 00544800436. These medical devices are intended for use in total knee arthroplasty where severe degeneration, trauma, or other pathology of the knee joint is present.

The recall was initiated because the products are potentially comingled, which means the product inside the box may not match the product described on the label. This discrepancy could lead to the implantation of the wrong size or type of augment during surgery.

The affected units were distributed worldwide, including nationwide in the United States (AL, CA, CO, ID, MS, NE, NJ, NY, OH, OR, PA, TX, VA, WI) and in Canada, Japan, Germany, and the Netherlands. Healthcare providers and patients should contact Zimmer Trabecular Metal Technology, Inc. for further instructions on how to handle the recalled devices.

The recalled product

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…
Manufacturer
Zimmer Trabecular Metal Technology, Inc.
Category
Medical Device — Orthopedic Implants
Hazard
Affected units
26

Distribution

Distributed nationwide across the United States.

The notice also names 14 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Zimmer Trabecular Metal Technology, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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