The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0075-2014·Announced 2013-11-06

Zimmer Natural-Knee Flex Femoral Component Packaging Adhesion Recall

Zimmer, Inc. is recalling Natural-Knee Flex Femoral Components because the low-density polyethylene packaging bags adhere to the polished device surfaces.

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, and the hazard is a packaging adhesion issue without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Zimmer, Inc. is recalling the Natural-Knee Flex Femoral Component, a medical device designed to provide increased flexion capability. The recall involves part numbers 00-5410, 5412, 5414, and 5416-013/018-01/02.

The recall was initiated because the low-density polyethylene (LDPE) bags used to package the implants adhere to the highly polished surface of the devices. This packaging defect may affect the handling or integrity of the implant packaging.

The affected devices were distributed worldwide, including the United States and numerous international markets such as Argentina, Australia, Brazil, Canada, China, Germany, India, Japan, and others. Healthcare providers and facilities that have received these specific part numbers should contact Zimmer, Inc. for instructions on how to proceed.

The recalled product

Product
Natural-Knee¿ Flex Femoral Component. Provides increased flexion capability.
Manufacturer
Zimmer, Inc.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
33,987

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 (4)

  • Part Number Range: 00-5410
  • 5412
  • 5414
  • and 5416-013/018-01/02.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 13 recalled by Zimmer, 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 13 products in this recall →

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