The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1032-2018·Announced 2018-03-21

Zimmer Biomet Recalls Hip and Knee Implants Due to Packaging Residue

Zimmer Biomet is recalling 13,227 hip and knee implants because LDPE packaging may leave residue on the polished 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 involves potential residue from packaging on medical implants, which is a moderate risk without reported injuries.

Plain-English summary

Zimmer Biomet, Inc. is recalling 13,227 units of CR-FLEX POR HATCP FEM hip and knee implants. The recall covers various sizes and configurations, including C, D, E, F, and G sizes in both left and right orientations.

The recall is due to a packaging issue 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 in the United States and countries such as Argentina, Australia, Brazil, Canada, China, India, Japan, and others. Consumers and healthcare providers should contact Zimmer Biomet for instructions on how to handle the recalled devices.

The recalled product

Product
CR-FLEX POR HATCP FEM C-L CR-FLEX POR HATCP FEM C-R CR-FLEX POR HATCP FEM D-L CR-FLEX POR HATCP FEM D-R CR-FLEX POR HATCP FEM E-L CR-FLEX POR HATCP FEM E-R CR-FLEX POR HATCP FEM F-L CR-FLEX POR HATCP FEM F-R CR-FLEX POR HATCP FEM G-L CR-FLEX POR HATCP FEM G-R This…
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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