Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0831-2016·Announced 2016-03-02

Zimmer Biomet Recalls NexGen CR-FLEX Knee Implants Due to Packaging Defect

Zimmer Biomet is recalling NexGen CR-FLEX knee prostheses because the LDPE packaging bag adheres to the implant surface. The recall covers 42,064 units distributed worldwide.

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. The hazard is a packaging defect (bag adhesion) which is a quality control issue rather than a direct biological or mechanical failure of the implant itself, fitting the criteria for moderate severity involving minor defects or low-risk issues.

Plain-English summary

Zimmer Biomet, Inc. is recalling NexGen CR-FLEX Option, Precoat, and Porous FEM knee prostheses. The recall is due to a defect where the low-density polyethylene (LDPE) bag containing the implant adheres to the highly polished implant surface. This issue affects 42,064 units of the device.

The affected products are semi-constrained, cemented knee prostheses indicated for patients with severe knee pain and disability due to conditions such as rheumatoid arthritis, osteoarthritis, and traumatic arthritis. The recall covers specific item numbers and lot numbers listed in the official FDA record. The devices were distributed nationwide in the United States and internationally to numerous countries including Argentina, Australia, Canada, and the United Kingdom.

Consumers and healthcare providers should contact Zimmer Biomet for instructions on how to handle the affected devices. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product: NexGen CR-FLEX Option FEM NexGen CR-FLEX Precoat FEM NexGen CR-FLEX Porous FEM prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer various sizes "" This device is indicated for patients with severe knee pain and disability due to…
Manufacturer: Zimmer Biomet, Inc.
Category: Medical Device — Orthopedic Implant
Hazard: packaging-defect
Affected units: 42,064

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 21 recalled by Zimmer Biomet, 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 21 products in this recall →

Same manufacturer · Zimmer Biomet, Inc.

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Same hazard · packaging defect