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, and the hazard involves packaging residue on the implant surface without reported 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 LPS-FLEX OPTION FEMORAL implants, which are indicated for patients with severe knee pain and disability. The recall covers various highly polished hip and knee implants distributed worldwide, including the United States and numerous international markets.
The recall was initiated 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 affected products are identified by specific catalog and serial numbers listed in the official recall notice. Consumers and healthcare providers should verify their inventory against the provided list of codes to determine if they possess affected units.
The recalled product
- Product
- LPS-FLEX OPTION FEMORAL C-L LPS-FLEX OPTION FEMORAL C-L LPS-FLEX OPTION FEMORAL C-R LPS-FLEX OPTION FEMORAL D-L LPS-FLEX OPTION FEMORAL D-R LPS-FLEX OPTION FEMORAL E-L LPS-FLEX OPTION FEMORAL E-R LPS-FLEX OPTION FEMORAL F-L LPS-FLEX OPTION FEMORAL F-R LPS-FLEX OPTION FEM
- Manufacturer
- Zimmer Biomet, Inc.
- 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 →Related recalls
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