Integra Layershield Adhesion Barrier Matrix Recalled for Pyrogen Levels
Integra LifeSciences is recalling 215 boxes of Layershield Adhesion Barrier Matrix because process deviations may have resulted in higher pyrogen levels than permitted.
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 potential safety hazard (excess pyrogens) that poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Integra LifeSciences Corporation is recalling 215 boxes of Layershield Adhesion Barrier Matrix. This product is an absorbable implant used as an adhesion barrier to reduce peridural fibrosis. The recall affects specific product lots identified by codes 1125812, 1125816, and 1126021.
The recall was initiated due to a process deviation that may have caused the affected product lots to be released with higher levels of pyrogens than permitted by the product specifications. Pyrogens are substances that can cause fever or other adverse reactions when introduced into the body.
The affected products were distributed worldwide, including nationwide in the United States (including Puerto Rico) and in countries such as the Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa. Healthcare providers and patients should stop using the affected lots and contact Integra LifeSciences Corporation for further instructions.
The recalled product
- Product
- Layershield Adhesion Barrier Matrix Layershield Adhesion Barrier Matrix is an absorbable implant for use as an adhesion barrier for the reduction of peridural fibrosis.
- Manufacturer
- Integra LifeSciences Corporation
- Hazard
- Affected units
- 215
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)
- 1125812 1125816 1126021
Distribution
Part of a larger recall action
This product is one of 21 recalled by Integra LifeSciences Corporation 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 21 products in this recall →Related recalls
Same manufacturer · Integra LifeSciences Corporation
See all →- ModerateIntegra Meshed Dermal Regeneration Template Recalled for Calculation Error
FDA (Devices) · 2016-09-21
- HighIntegra Recalls Mayfield Ultra 360 Base Units Due to Locking Handle Failure
FDA (Devices) · 2015-02-18
- ModerateIntegra Newdeal SURFIX Screws Recalled for Packaging Labeling Error
FDA (Devices) · 2014-06-11
- HighIntegra PANTA Arthrodesis Nail System Recalled for Screw Misalignment
FDA (Devices) · 2013-07-24
- HighIntegra Recalls BioMend Extend Membranes Due to Pyrogen Levels
FDA (Devices) · 2013-05-22
Same hazard · pyrogen contamination
See all →- HighIntegra Recalls DuraGen XS Dural Regeneration Matrix Due to Pyrogen Levels
FDA (Devices) · 2013-05-22
- ModerateIntegra Recalls DuraGen Dural Graft Matrix Due to Pyrogen Levels
FDA (Devices) · 2013-05-22
- HighIntegra Ora Plug Collagen Wound Dressing Recalled for Pyrogen Levels
FDA (Devices) · 2013-05-22
- ModerateIntegra Recalls DuraGen Plus Matrix Due to Pyrogen Levels
FDA (Devices) · 2013-05-22