The Recall Desk
ModerateFDA (Devices)·Z-1056-2018·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 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, but the source text does not report any illnesses or injuries, and the hazard is a packaging defect that may leave residue, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Zimmer Biomet, Inc. is recalling 13,227 units of LPS-FLEX hip and knee implants. The affected products were distributed nationwide in the US and in 24 other countries, including Argentina, Australia, Brazil, and Canada.

The recall is due to a packaging defect where the LDPE bag may adhere to the highly polished surface of the implants. This adhesion can leave residue or material from the bag on the implant after it is removed from the packaging.

The source text does not report any illnesses, injuries, or deaths associated with this recall. Consumers and healthcare providers should check their inventory for the specific lot numbers listed in the official recall notice and contact Zimmer Biomet for instructions on how to proceed.

The recalled product

Product
LPS-FLEX GSF OPT SZ C-L¿ LPS-FLEX GSF OPT SZ C-R¿ LPS-FLEX GSF OPT SZ D-L¿ LPS-FLEX GSF OPT SZ D-R¿ LPS-FLEX GSF OPT SZ E-L¿ LPS-FLEX GSF OPT SZ E-R¿ LPS-FLEX GSK OPT SZ F-L¿ LPS-FLEX GSF OPT SZ F-R¿ LPS-FLEX GSF OPT SZ G-L¿ LPS-FLEX GSF OPT SZ G-R¿
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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