Zimmer Biomet Recalls Polyethylene Hip Implants Due to Endotoxin Levels
Zimmer Biomet is recalling 28,253 polyethylene hip implant components worldwide because endotoxin levels exceeded process maximum limits.
What this means for you
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 is classified as FDA Class II. The hazard involves endotoxin contamination in medical implants, which poses a risk of harm, but the source text does not report specific illnesses or injuries, fitting the criteria for a High severity score.
Plain-English summary
Zimmer Biomet, Inc. is recalling 28,253 units of various polyethylene implants used in hip arthroplasty. The affected products include Active Articulation ArComXL Bearings, Active Articulation E1 Bearings, Arcos Taper Cap, BIOLOX delta Option Head, E1 RingLoc Bi-Polar, Freedom Constrained Liner +5mm, Hi-Wall ArcomXL All Poly, Rimloc E1 10 Degree Liner, RingLoc +3mm Hi-Wall E1 Liner, and other specific liners and bearings.
The recall was initiated because endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components. The agency classification for this recall is Class II.
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 contact Zimmer Biomet for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- various polyethylene implants Hips Active Articulation ArComXL Bearings Active Articulation E1 Bearings Arcos Taper Cap BIOLOX delta Option Head E1 RingLoc Bi-Polar Freedom Constrained Liner +5mm Hi-Wall ArcomXL All Poly Rimloc E1 10 Degree Liner RingLoc +3mm Hi-Wall
- 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
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