Layershield Adhesion Barrier Matrix Layershield recall
Layershield Adhesion Barrier Matrix Layershield Adhesion Barrier Matrix is an absorbable implant for use as an adhesion barrier for the reduction of…
Why was Layershield Adhesion Barrier Matrix Layershield recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
1125812 1125816 1126021
- Product
- Layershield Adhesion Barrier Matrix Layershield Adhesion Barrier Matrix is an absorbable implant for use as an adhesion barrier for the reduction of…
- Recalling firm
- Integra LifeSciences Corporation
- Quantity
- 215 boxes
- Distribution
- 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.
- Recall date
- May 22, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)