Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1005-2019·Announced 2019-03-20

Zimmer NexGen Trabecular Metal Tibial Augment Recall for Label Mismatch

Zimmer Trabecular Metal Technology is recalling 24 units of NexGen 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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard is a labeling/packaging mismatch (commingling) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Zimmer Trabecular Metal Technology, Inc. is recalling 24 units of the NexGenTrabecular Metal Tibial Half Block Augment, Right Lateral/Left Medial, Size 4 5MM Thickness W/Screws (Item Number: 00544800426). The recall is due to a potential commingling issue where the product inside the box may not match the product identified on the label.

The affected products are distributed worldwide, including 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. The specific lot numbers involved are 63253751, 63257915, and 63291542.

Healthcare providers and facilities should check their inventory for these specific lot numbers and item numbers. If the product is found, it should be removed from use and returned to the manufacturer or authorized representative. Patients who have already received this implant should contact their surgeon or healthcare provider for guidance.

The recalled product

Product: NexGenTrabecular Metal Tibial Half Block Augment, Right Lateral/Left Medial, Size 4 5MM Thickness W/Screws Item Number: 00544800426 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 Implant
Hazard: mis-labeling
packaging-error
Affected units: 24

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 →

Same manufacturer · Zimmer Trabecular Metal Technology, Inc.

See all →

High
FDA Recalls NexGen Trabecular Metal Tibial Augments Due to Labeling Mismatch
FDA (Devices) · 2019-03-20
Low
Zimmer TM Ardis Interbody System Recalled for Procedural Error in Literature Approval
FDA (Devices) · 2017-05-10
High
Zimmer Trabecular Metal Implants Recalled for Sterile Integrity Concerns
FDA (Devices) · 2016-06-22
High
Zimmer Biomet Recalls Specific Lots of Trabecular Metal Implants
FDA (Devices) · 2016-06-22
High
Zimmer Trabecular Metal Implants Recalled for Sterile Integrity Concerns
FDA (Devices) · 2016-06-22

Same hazard · mis labeling