Integra LifeSciences Corporation: Medical Device Recall in 2013 - (Recall #: Z-1285-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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 use in double peel packages in a variety of sizes.

Product Classification:

Class II

Date Initiated: March 28, 2013

Date Posted: May 22, 2013

Recall Number: Z-1285-2013

Event ID: 64778

Reason for Recall:

Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.

Status: Terminated

Product Quantity: 52 boxes

Code Information:

1125963, 1130387 1130386, 1130468

Distribution Pattern:

Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa.

Voluntary or Mandated:

Voluntary: Firm initiated