The Recall Desk
ModerateFDA (Devices)·Z-1045-2018·Announced 2018-03-21

Zimmer Biomet Recalls NEXGEN LPS-FLEX Knee Implants Due to Packaging Residue

Zimmer Biomet is recalling NEXGEN LPS-FLEX knee implants because LDPE packaging may leave residue on the polished surface.

What this means for you

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 involves packaging residue on a medical device without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Zimmer Biomet, Inc. is recalling 13,227 units of NEXGEN LPS-FLEX PRECOAT FEMORAL SIZE E-LT knee implants. The device is indicated for patients with severe knee pain and disability. The recall is due to a defect in the LDPE bag packaging, which may adhere to the highly polished surface of the implant. This adhesion can leave residue or material from the bag on the implant after it is removed from the packaging.

The affected products were distributed worldwide, including nationwide in the United States and in countries such as Argentina, Australia, Brazil, Bolivia, Canada, Chile, China, Colombia, Ecuador, El Salvador, India, Japan, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Panama, Seoul-Korea, Singapore, Taiwan, Thailand, and UAE. The specific code information for the recalled items is 00-5962-015-52 11006115.

Consumers and healthcare providers should contact Zimmer Biomet, Inc. for further instructions regarding the return or replacement of these devices. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
NEXGEN LPS-FLEX PRECOAT FEMORAL SIZE E-LT This device is indicated for patients with severe knee pain and disability
Manufacturer
Zimmer Biomet, Inc.
Category
Medical Device — Orthopedic Implants
Hazard
Affected units
13,227

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 (1)

  • 00-5962-015-52 11006115

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 48 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 48 products in this recall →

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