The Recall Desk
ModerateFDA (Devices)·Z-1034-2018·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 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, and the hazard involves packaging residue on a medical device without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Zimmer Biomet, Inc. is recalling 13,227 LPS FEM IMPLANT SZ H-R devices. These medical implants are indicated for patients with severe knee pain and disability. The recall covers units distributed nationwide in the US and in 24 other countries, including Argentina, Australia, Brazil, and Japan.

The recall was initiated because the LDPE bag packaging used for these highly polished implants may adhere to the surface. This adhesion can leave residue or material from the bag on the implant after it is removed from the packaging.

Consumers and healthcare providers should contact Zimmer Biomet for further instructions regarding the affected devices. The specific code information for the recalled units is 00-5996-018-92 61836677.

The recalled product

Product
LPS FEM IMPLANT SZ H-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

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 (1)

  • 00-5996-018-92 61836677

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 →

Related recalls

Same manufacturer · Zimmer Biomet, Inc.

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Same hazard · packaging residue

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