Z-1298-2013 Class II Terminated
FDA device recall Z-1298-2013 was initiated by Integra LifeSciences Corporation on March 28, 2013 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated June 3, 2015). Affected quantity: 812 boxes.
Recall Details
- Product Type
- Devices
- Report Date
- May 22, 2013
- Initiation Date
- March 28, 2013
- Termination Date
- June 3, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 812 boxes
Product Description
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.
Reason for Recall
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.
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.
Code Information
1112066