Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1054-2018·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.

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, but the source text does not report any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Zimmer Biomet, Inc. is recalling 13,227 units of the Zimmer Unicompartmental Knee System (ZUK) and related femoral components. The recall covers specific sizes and configurations, including ZUK PRC FEM SZB through SZF and NGU PRC FEM SZD models. These devices are indicated for patients with painful or disabling knee joints due to osteoarthritis, traumatic arthritis, previous fractures, or deformities, and are designed for cemented use only.

The recall is issued because the LDPE bag packaging for these highly polished implants may adhere to the surface. This adhesion can leave residue or material from the LDPE bag on the implant after it is removed from the packaging. The affected units were distributed worldwide, including in the United States and countries such as Argentina, Australia, Brazil, Canada, China, India, Japan, and the United Arab Emirates.

Consumers and healthcare providers should contact Zimmer Biomet for further instructions regarding the return or replacement of these devices. The source text does not report any specific illnesses or injuries associated with this packaging issue.

The recalled product

Product: ZUK PRC FEM SZB RMED/LLAT¿ ZUK PRC FEM SZC LMED/RLAT¿ ZUK PRC FEM SZC RMED/LLAT¿ NGU PRC FEM SZD LMED/RLAT¿ ZUK PRC FEM SZD RMED/LLAT¿ ZUK PRC FEM SZE LMED/RLAT ZUK PRC FEM SZF RMED/LLAT " These devices are indicated for patients with: - Painful and/or disabling knee…
Manufacturer: Zimmer Biomet, Inc.
Category: Medical Device — Orthopedic Implants
Hazard: packaging-residue
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 →

Same manufacturer · Zimmer Biomet, Inc.

See all →

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Same hazard · packaging residue