Integra Recalls DuraGen XS Dural Regeneration Matrix Due to Pyrogen Levels
Integra LifeSciences is recalling 52 boxes of DuraGen XS Dural Regeneration Matrix because process deviations may have resulted in higher levels of pyrogens 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 process deviation leading to higher pyrogen levels, which poses a risk of harm (fever/inflammation) to patients, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Integra LifeSciences Corporation is recalling 52 boxes of DuraGen XS Dural Regeneration Matrix. This product is an absorbable implant used for the repair of dural defects. The recall is due to a process deviation that may have caused the product lots to be released with higher levels of pyrogens than permitted by the product specifications.
The affected product is supplied sterile and non-pyrogenic for single use in double peel packages. The recall covers lots with codes 1125963, 1130387, 1130386, and 1130468. The product was distributed worldwide, including the United States (nationwide), Puerto Rico, and various international locations such as Canada, Japan, and the United Kingdom.
Healthcare providers and facilities should stop using the affected product and contact Integra LifeSciences for instructions on how to return or dispose of the recalled items.
The recalled product
- Product
- DuraGen XS Dural Regeneration Matrix DuraGen XS Dural Regenerative Matrix is an absorbable implant for repair of dural defects. DuraGen XS is an easy to handle, soft, white, pliable, non-friable, porous collagen matrix. DuraGen XS is supplied sterile, non-pyrogenic, for single
- Manufacturer
- Integra LifeSciences Corporation
- Hazard
- Affected units
- 52
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 (3)
- 1125963
- 1130387 1130386
- 1130468
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 →- 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
- HighIntegra Layershield Adhesion Barrier Matrix Recalled for Pyrogen Levels
FDA (Devices) · 2013-05-22
- ModerateIntegra Recalls DuraGen Plus Matrix Due to Pyrogen Levels
FDA (Devices) · 2013-05-22