The Recall Desk
ModerateFDA (Devices)·Z-1284-2013·Announced 2013-05-22

Integra Recalls DuraGen Plus Matrix Due to Pyrogen Levels

Integra LifeSciences is recalling DuraGen Plus Dural Regeneration Matrix because process deviations may have resulted in higher levels of pyrogens than permitted.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Integra LifeSciences Corporation is recalling 21,179 boxes of DuraGen Plus Dural Regeneration Matrix. This absorbable implant is used for the repair and restoration of dural defects and as an adhesion barrier to reduce peridural fibrosis. The product is supplied sterile and nonpyrogenic for single use.

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 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 check their inventory and records for the specific lot numbers listed in the recall notice to determine if they are affected.

The recalled product

Product
DuraGen Plus Dural Regeneration Matrix DuraGen Plus Adhesion Barrier Matrix is an absorbable implant for repair and restoration of dural defects and as an adhesion barrier for the reduction of peridural fibrosis. DuraGen Plus matrix is an easy to handle, soft, white pliable, n
Manufacturer
Integra LifeSciences Corporation
Category
Medical Device — Surgical Implants
Hazard
Affected units
21,179

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 (20)

  • 1125523
  • 1125517 1125522
  • 1125539 1125524
  • 1125525 1125526
  • 1125632 1125630
  • 1125678 1125679 1125677
  • 1125683 1125628
  • 1125813 1125814
  • 1125815 1125629
  • 1125520 1125521
  • 1125979 1126031
  • 1125980 1125981
  • 1125982 1126030
  • 1130243 1130071
  • 1130503 1130379
  • 1130381 1130384
  • 1130507 1130374
  • 1130380 1130382
  • 1130421 1130505
  • 1130424 1130654

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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

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Same hazard · pyrogen contamination

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