Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2115-2017·Announced 2017-05-24

Zimmer Biomet Recalls NexGen Offset Stem Extension Implants Due to Labeling Errors

Zimmer Biomet is recalling specific lots of NexGen Offset Stem Extension implants because the size etched on the parts and packaging was incorrect.

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 error (incorrect size) which is a moderate risk of harm but does not involve reported injuries or high-risk pathogens.

Plain-English summary

Zimmer Biomet, Inc. is conducting a lot-specific field action for two lots of NexGen Offset Stem Extension implants, sizes 14mm and 17mm. These medical devices are used in total arthroplasty procedures. The recall involves 24 units distributed worldwide, including the United States and several international countries.

The field action was initiated because product complaints indicated that the size etched on the implant parts and the size labeled on the product packaging were incorrect. This discrepancy creates a risk of using the wrong size implant during surgery.

Healthcare providers and facilities that have received these specific lots should stop using the affected devices and contact Zimmer Biomet for instructions on how to return or dispose of them. Patients who have already had these implants placed should contact their surgeon or healthcare provider to discuss the potential implications of the labeling error.

The recalled product

Product: NexGen Offset Stem Extension, sizes 14mm and 17mm For use in total arthroplasty.
Manufacturer: Zimmer Biomet, Inc.
Category: Medical Device — Orthopedic Implants
Hazard: mis-labeling
Affected units: 24

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (9)

Item Number: 00-5988-020-14
Lot Number: 63463357
Description: NexGen Offset Stem Ext Size 14
UDI: (01)00889024221475(17)260930(10)63463357
Item Number: 00-5988-020-17
Lot Number: 63463367
Description: (01)00889024221505(17)260930(10)63463367
Manufactured Date: 9/19/2016
Expiration Date: 9/30/2026

Distribution

Distributed in 9 states:

Same manufacturer · Zimmer Biomet, Inc.

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Same hazard · mis labeling