The Recall Desk
ModerateFDA (Devices)·Z-1055-2018·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 bag packaging may leave residue on the polished surfaces.

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 potential residue from packaging on the implant surface. No specific injuries or illnesses are reported in the source text, fitting the criteria for a moderate severity recall involving low-risk contamination or precautionary measures.

Plain-English summary

Zimmer Biomet, Inc. is recalling 13,227 units of the Zimmer Unicompartmental Knee System. The affected devices are various highly polished hip and knee implants, including specific femoral and tibial components in small, regular, and large sizes. These devices are indicated for patients with painful or disabling knee joints due to osteoarthritis or traumatic arthritis, previous fractures, deformities, or revision of previous arthroplasty procedures.

The recall is being issued because the LDPE bag packaging for these implants may adhere to the highly polished surface. This adhesion can leave residue or material from the LDPE bag on the implant after it is removed from the packaging. The devices are indicated for cemented use only and are designed for use when load-bearing range of motion is expected to be less than or equal to 155 degrees.

The affected units were distributed worldwide, including nationwide in the United States and in countries such as Argentina, Australia, Brazil, Canada, China, India, Japan, and others. Consumers and healthcare providers should contact Zimmer Biomet for further instructions on how to handle the affected devices.

The recalled product

Product
FEM PRC LT M/RT L SML FEM PRC RT M/LT L SML FEM PRC LT M/RT L SML+ FEM PRC RT M/LT L SML+ FEM PRC LT M/RT L REG FEM PRC RT M/LT L REG FEM PRC LT M/RT L REG+ FEM PRC RT M/LT L REG+ FEM PRC LT M/RT L LGE
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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