The Recall Desk
ModerateFDA (Devices)·Z-1282-2013·Announced 2013-05-22

Integra Recalls DuraGen Dural Graft Matrix Due to Pyrogen Levels

Integra LifeSciences is recalling DuraGen Dural Graft 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, and the hazard involves a process deviation resulting in higher pyrogen levels than permitted. No specific injuries or illnesses are reported in the source text, fitting the criteria for a moderate severity recall.

Plain-English summary

Integra LifeSciences Corporation is recalling DuraGen Dural Graft Matrix, an absorbable implant used for the repair of dural defects. The recall involves 15,607 boxes of the product that were distributed worldwide, including the United States (nationwide and Puerto Rico) and numerous international locations.

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. DuraGen is supplied sterile and nonpyrogenic for single use.

Healthcare providers and facilities that have received this product should stop using it and contact Integra LifeSciences Corporation for further instructions on how to return or dispose of the affected lots.

The recalled product

Product
Dural Graft Matrix DuraGen¿ Dural Graft Matrix is an absorbable implant for repair of dural defects. DuraGen matrix is an easy to handle, soft, white, pliable, nonfriable, porous collagen matrix. DuraGen matrix is supplied sterile, nonpyrogenic, for single use in double peel
Manufacturer
Integra LifeSciences Corporation
Category
Medical Device — Surgical Implants
Hazard
Affected units
15,607

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)

  • 1125807
  • 1125802
  • 1125806
  • 1125804
  • 1125808
  • 1111845
  • 1125805
  • 1125803
  • 1125809
  • 1125810
  • 1130069
  • 1130061
  • 1130064
  • 1130065
  • 1130417
  • 1130521
  • 1110850
  • 1111839
  • 1111621
  • 1110274

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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