Zimmer Biomet Recalls Polyethylene Implants Due to High Endotoxin Levels
Zimmer Biomet is recalling 28,253 custom polyethylene implants because endotoxin levels exceeded process maximum limits. The affected parts were distributed worldwide.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a contamination hazard (endotoxin) that poses a risk of harm, but the source text does not report any specific illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Zimmer Biomet, Inc. is recalling 28,253 units of various custom polyethylene implants. The recall was initiated because endotoxin levels in the identified polyethylene components were discovered to be higher than process maximum limits.
The affected products were distributed worldwide, including in the United States, Argentina, Australia, Canada, Chile, China, Costa Rica, Ecuador, India, Italy, Japan, South Korea, Malaysia, Mexico, Panama, Singapore, Switzerland, Thailand, and the United Kingdom.
Consumers and healthcare providers should stop using the affected polyethylene components and contact Zimmer Biomet for further instructions on the recall.
The recalled product
- Product
- various polyethylene implants Custom parts Product Usage: Custom
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 28,253
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 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 6 products in this recall →Related recalls
Same manufacturer · Zimmer Biomet, Inc.
See all →- HighZimmer Biomet Recalls Spinal Rod Cutters Due to Fracture Risk
FDA (Devices) · 2020-12-30
- ModerateZimmer Biomet Recalls Polaris Spinal System Screws for Labeling Update
FDA (Devices) · 2020-12-23
- HighZimmer Biomet Recalls Hip Prosthesis Cups Due to Sterilant Biocompatibility Concerns
FDA (Devices) · 2020-11-11
- HighZimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns
FDA (Devices) · 2020-11-11
- HighZimmer Biomet Recalls Hip Prosthesis Component Due to Sterilant Concerns
FDA (Devices) · 2020-11-11
Same hazard · endotoxin contamination
See all →- HighMedline Medical Convenience Kits Recalled for Endotoxin Levels
FDA (Devices) · 2026-09-02
- HighCardinal Health Presource Kits Recalled for Endotoxin Variability
FDA (Devices) · 2026-08-19
- HighCardinal Health Presource Kits Recalled for Endotoxin Variability in Sponges
FDA (Devices) · 2026-08-19
- HighNeurological Sponges Recalled Due to Potential Variability in Endotoxin Levels
FDA (Devices) · 2026-08-05
- HighMedline Medical Procedure Kits with Neuro Sponges Recalled for Endotoxin
FDA (Devices) · 2026-05-06
Similar recalls
- HighZimmer Biomet Recalls Custom Medical Devices Due to Cleaning Issues
FDA (Devices) · 2019-12-04
- ModerateZimmer Segmental Systems Polyethylene Inserts Recalled for Loading Instructions
FDA (Devices) · 2014-01-29
- HighBiomet Recalls Shoulder Implant Components Due to Endotoxin Levels
FDA (Devices) · 2020-06-03
- HighZimmer Biomet Recalls Custom Medical Devices Due to Packaging Adhesion
FDA (Devices) · 2019-11-13
- HighZimmer Biomet Recalls Custom Shoulder Implants Due to Cleaning Issues
FDA (Devices) · 2019-12-04
- ModerateZimmer Biomet Recalls Hip Implants Due to Packaging Residue
FDA (Devices) · 2018-03-21