Integra Recalls OraMem Absorbable Collagen Membrane Due to Pyrogen Levels
Integra LifeSciences is recalling 812 boxes of OraMem Absorbable Collagen Membrane because process deviations may have resulted in higher levels of pyrogens than permitted.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk-of-harm product (pyrogens) where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Integra LifeSciences Corporation is recalling 812 boxes of OraMem Absorbable Collagen Membrane. This absorbable, implantable material is indicated for guided tissue regeneration procedures in periodontal defects to enhance regeneration of the periodontal apparatus.
The recall was initiated due to a process deviation. As a result, the affected product lots may have been released with higher levels of pyrogens than permitted by the product specifications.
The affected product was distributed worldwide, including the United States (nationwide) and Puerto Rico, as well 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. The specific lot code is 1112066. Healthcare providers and patients should contact their healthcare provider or the manufacturer for further instructions regarding the use or removal of the device.
The recalled product
- Product
- OraMem Absorbable Collagen Membrane OraMem¿ Absorbable Collagen Membrane is an absorbable, implantable material that is indicated for guided tissue regeneration procedures in periodontal defects to enhance regeneration of the periodontal apparatus.
- Manufacturer
- Integra LifeSciences Corporation
- Hazard
- Affected units
- 812
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 (1)
- 1112066
Distribution
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.
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