Device product
BioMend¿ Extend" Absorbable Collagen Membrane BioMend¿ Extend" 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.
Z-1299-2013
Product summary
- Event
- Event 64778
- Status
- Terminated
- Classification
- Class II
- Quantity
- 20,032 boxes
- Official record key
device-enforcement:Z-1299-2013
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: 1104846, 1105175 1105253, 1110810 1110811, 1111149 1111859, 1104847 1105176, 1105254 1110809, 1111860 1104848, 1110819 1110820, 1111148 1111861
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
process deviation