Zimmer Biomet Recalls Polyethylene Implants Due to High Endotoxin Levels
Zimmer Biomet is recalling BIO PLUG 10MM polyethylene implants 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 involves a medical device with a contamination issue (endotoxins) that poses a risk of harm, but the source text does not report any specific illnesses or injuries, fitting the criteria for a High severity score.
Plain-English summary
Zimmer Biomet, Inc. is recalling 28,253 units of BIO PLUG 10MM polyethylene implants. These are sterile, non-bioabsorbable, implantable devices designed to be inserted into the medullary canal of a bone during orthopedic surgery to prevent cement progression.
The recall was initiated because endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components. The affected product is Item 163005, Lot 309030.
The products were distributed worldwide, including in the United States, Argentina, Australia, Canada, Chile, China, Costa Rica, Ecuador, GSCC, India, Italy, Japan, South Korea, Malaysia, Mexico, Panama, Singapore, Switzerland, Thailand, and the UK. Healthcare providers and patients should contact Zimmer Biomet for further instructions regarding the removal or replacement of these devices.
The recalled product
- Product
- various polyethylene implants BIO PLUG 10MM Product Usage: Non-weight bearing accessory. Sterile, optional speciality components that are non-bioabsorbable, implantable devices designed to be inserted into the medullary canal of a bone during orhtopedic surgery to preve
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 28,253
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)
- Item 163005 Lot 309030
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.
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