The Recall Desk
ModerateFDA (Devices)·Z-1283-2013·Announced 2013-05-22

Integra Recalls Suturable DuraGen Dural Matrix Due to Pyrogen Levels

Integra LifeSciences is recalling Suturable DuraGen Dural Regenerative Matrix because process deviations may have resulted in higher pyrogen levels 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 or injuries. The hazard is a potential deviation from specifications (pyrogen levels) without confirmed adverse health consequences, fitting the criteria for a moderate severity score.

Plain-English summary

Integra LifeSciences Corporation is recalling 4,799 boxes of Suturable DuraGen Dural Regenerative Matrix. This absorbable implant is used for the repair of dural defects and is supplied sterile and non-pyrogenic 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. The affected lots are identified by specific codes listed in the recall documentation.

The product was distributed worldwide, including the United States (nationwide, including Puerto Rico) and numerous international markets. Healthcare providers and facilities that have received this product should stop using it and contact the manufacturer for further instructions.

The recalled product

Product
Suturable DuraGen Dural Regenerative Matrix Suturable DuraGen Dural Regenerative Matrix is an absorbable implant for repair of dural defects. Suturable DuraGen is an easy to handle, soft, white, pliable, nonfriable, porous collagen matrix with a mechanically strengthened colla
Manufacturer
Integra LifeSciences Corporation
Category
Medical Device — Surgical Implants
Hazard

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 (11)

  • 1125682
  • 1125681 1125817
  • 1125983
  • 1126018 1126019
  • 1130641 1130642
  • 1110848
  • 1110849 1111883
  • 1111354
  • 1111884 1111936
  • 1112151 1110256
  • 1111355

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

See all →

Same hazard · pyrogen

See all →