The Recall Desk
ModerateFDA (Devices)·Z-1293-2013·Announced 2013-05-22

Integra Recalls CollaPlug Collagen Wound Dressings Due to Pyrogen Levels

Integra LifeSciences is recalling 155,850 boxes of CollaPlug Absorbable Collagen Wound Dressings for dental surgery 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 illnesses, injuries, or hospitalizations. The hazard is a potential specification deviation (pyrogens) without confirmed adverse health consequences, fitting the criteria for a moderate severity score.

Plain-English summary

Integra LifeSciences Corporation is recalling 155,850 boxes of CollaPlug Absorbable Collagen Wound Dressings for Dental Surgery. These products are intended for use on moist or bleeding oral wounds to help stabilize blood clots and protect the wound surface. 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 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. Specific lot codes are listed in the official recall notice.

Consumers and healthcare providers should stop using the affected products and contact their supplier or Integra LifeSciences for further instructions. The FDA has classified this as a Class II recall.

The recalled product

Product
CollaPlug Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury. Topical
Manufacturer
Integra LifeSciences Corporation
Category
Medical Device — Wound Care
Hazard
Affected units
155,850

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)

  • 1104500
  • 1104623 1105315
  • 1105316 1105317
  • 1110234 1110235
  • 1110236 1110237
  • 1110238 1110239
  • 1110240 1110784
  • 1111151 1111152
  • 1111153 1111155
  • 1111156 1111157
  • 1111646 1105300

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 →

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Same hazard · pyrogens

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