The Recall Desk
ModerateFDA (Devices)·Z-1044-2018·Announced 2018-03-21

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

Zimmer Biomet is recalling 13,227 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 the implant surface without reported injuries or illnesses, fitting the criteria for a moderate severity rating.

Plain-English summary

Zimmer Biomet, Inc. is recalling 13,227 units of LPS-FLEX Precoat Femoral and Porous Femoral knee implants. The recall covers various sizes and configurations, including B-R, C-L, C-R, D-L, D-R, E-L, E-R, F-L, F-R, G-L, G-R, H-L, and H-R models, as well as the Porous Femoral E-R model.

The reason for the recall is that the LDPE bag packaging for these highly polished implants may adhere to the surface. This adhesion can leave residue or material from the LDPE bag on the implant after it is removed from the packaging.

The affected devices 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. These devices are indicated for patients with severe knee pain and disability. Healthcare providers should contact Zimmer Biomet for instructions on how to handle the recalled devices.

The recalled product

Product
LPS-FLEX PRECOAT FEMORAL B-R LPS-FLEX PRECOAT FEMORAL C-L LPS-FLEX PRECOAT FEMORAL C-R LPS-FLEX PRECOAT FEMORAL D-L LPS-FLEX PRECOAT FEMORAL D-R LPS-FLEX PRECOAT FEMORAL E-L LPS-FLEX PRECOAT FEMORAL E-R LPS-FLEX PRECOAT FEMORAL F-L LPS-FLEX PRECOAT FEMORAL F-R LPS-FLEX P
Manufacturer
Zimmer Biomet, Inc.
Category
Medical Device — Orthopedic Implants
Hazard
Affected units
13,227

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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