NexGen CR-Flex Femoral Components Recalled for Bonding Defect

Plain-English summary

Zimmer, Inc. is recalling 5,546 units of NexGen CR-Flex Femoral Components (Size E and Size E Minus models), which are components of the NexGen CR-Flex Porous Femur System. The recalled devices were distributed worldwide, including throughout the United States, Australia, Canada, Japan, and the Netherlands.

The recall stems from an out-of-specification manufacturing defect. A gap in the fixture that presses the fiber metal pad to the substrate causes the pad to fail to bond fully to the substrate. This affects the performance of the implant component.

Patients who have received these components should contact their healthcare provider to determine if their implant is affected. Healthcare providers should immediately stop using affected inventory and refer to FDA and Zimmer communications regarding the specific lot codes associated with the recall.

The recalled product

Product

NexGen CR-Flex Femoral Component, Size E and Size E Minus (E-). Component of the NexGen CR-Flex Porous Femur System.

Manufacturer

Zimmer, Inc.

Category

Medical Device — Orthopedic Implant Component

Hazard

• bonding-failure
• manufacturing-defect

Is your product affected?

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

Distribution

Distributed nationwide across the United States.

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