The Recall Desk
ModerateFDA (Devices)·Z-1038-2018·Announced 2018-03-21

Zimmer Biomet Recalls Hip and Knee Implants Due to Packaging Residue

Zimmer Biomet is recalling specific hip and knee implants because the packaging bags 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 packaging residue on the device surface without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Zimmer Biomet, Inc. is recalling 13,227 units of LPS Porous Fem Implant and LPS Precoat Fem Implant, sizes G-L. These medical devices are indicated for patients with severe knee pain and disability.

The recall was initiated because the LDPE bag packaging 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.

The affected products were distributed worldwide, including the United States and numerous international locations such as Argentina, Australia, Brazil, Canada, China, India, Japan, and the United Arab Emirates. Patients who have received these implants should contact their healthcare provider for guidance.

The recalled product

Product
LPS POROUS FEM IMPLANT SZ G-L LPS PRECOAT FEM IMPLANT SZ G-L 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)

  • 00-5992-017-91 61928631 00-5990-017-91 61771841

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.

See all →

Same hazard · packaging residue

See all →