The Recall Desk
ModerateFDA (Devices)·Z-1051-2018·Announced 2018-03-21

Zimmer Biomet Recalls Knee Implants Due to Packaging Residue

Zimmer Biomet is recalling 13,227 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, but the source text describes a packaging defect (residue) without reporting any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Zimmer Biomet, Inc. is recalling 13,227 units of PRCT MIS CR MOB PLT knee implants. The affected devices are indicated for patients with severe knee pain and disability. The recall covers specific sizes (4, 5, 6, 7, and 8) for both left and right knees.

The recall is due to a defect in the LDPE bag packaging. The packaging may adhere to the highly polished surface of the implants, potentially leaving residue or material from the bag on the implant after it is removed. This issue affects the integrity of the implant surface.

The affected products 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 proceed with the affected devices.

The recalled product

Product
PRCT MIS CR MOB PLT SZ 4 L¿ PRCT MIS CR MOB PLT SZ 5 L¿ PRCT MIS CR MOB PLT SZ 6 L¿ PRCT MIS CR MOB PLT SZ 7 L¿ PRCT MIS CR MOB PLT SZ 7 R¿ PRCT MIS CR MOB PLT SZ 8 L¿ PRCT MIS CR MOB PLT SZ 8 R 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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