The Recall Desk
ModerateFDA (Devices)·Z-1048-2018·Announced 2018-03-21

Zimmer Biomet Recalls Knee Implants Due to Packaging Residue

Zimmer Biomet is recalling 13,227 CR-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 CR-FLEX POR FEM F-L, CR-FLEX POR FEM F-R MINUS, and CR-FLEX POR FEM G-L knee implants. These devices are indicated for patients with severe knee pain and disability. The recall covers specific lot codes: 00-5952-016-01 61774124, 00-5952-016-01 61782595, 00-5952-016-06 11004288, and 00-5952-017-01 11005095.

The recall is due to a packaging defect where the LDPE bag may adhere to the highly polished surface of the implants. This adhesion can leave residue or material from the bag on the implant after it is removed from the packaging.

The affected devices were distributed worldwide, including the United States (nationwide) and 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. Healthcare providers should contact Zimmer Biomet for instructions on handling the affected units.

The recalled product

Product
CR-FLEX POR FEM F-L CR-FLEX POR FEM F-R MINUS CR-FLEX POR FEM G-L 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

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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