FDA Device recall Z-1300-2013
Layershield Adhesion Barrier Matrix Layershield Adhesion Barrier Matrix is an absorbable implant for use as an adhesion barrier for the red…
- FDA Device
- Class II
- terminated
- Published 2013-05-22
On 2013-05-22 the FDA classified a Class II recall of Layershield Adhesion Barrier Matrix Layershield Adhesion Barrier Matrix is an absorbable implant for use as an adhesion barrier for the red… by Integra Lifesciences, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1300-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-03-28 |
| Published | 2013-05-22 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Integra Lifesciences |
| Distribution | US |
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.
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.
Identifiers
| code_info | 1125812 1125816 1126021 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1300-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.