Skip to content
Recall Observatory FDA recall evidence

Device product

OraTape 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 administration of the Absorbable Collagen Wound Dressings directly over the wound effectively controls bleeding usually within two to five minutes.

Z-1296-2013

March 28, 2013

Class II

Product summary

Firm
Integra LifeSciences Corporation
Event
Event 64778
Status
Terminated
Classification
Class II
Quantity
17,110 boxes
Official record key
device-enforcement:Z-1296-2013

Official wording

Reason: 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.

Code information: 1126012, 1105396 1105397, 1105398 1105399, 1111364 1111641

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.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    process deviation