Device product
Layershield Adhesion Barrier Matrix Layershield Adhesion Barrier Matrix is an absorbable implant for use as an adhesion barrier for the reduction of peridural fibrosis.
Z-1300-2013
Product summary
- Event
- Event 64778
- Status
- Terminated
- Classification
- Class II
- Quantity
- 215 boxes
- Official record key
device-enforcement:Z-1300-2013
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: 1125812 1125816 1126021
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