TEI Biosciences, Inc. Recall 92481
Description: SurgiMend PRS Meshed; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Size 10cm x 20cm
TEI Biosciences, Inc. Recall 92481 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2076-2023 |
| Event ID | 92481 |
| Event Description | SurgiMend PRS Meshed; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Size 10cm x 20cm |
| Product Type | Devices |
| Distribution | Domestic: Nationwide Distribution. |
| Quantity | 9,215 units |
| Recall Reason | Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing. |
| Device Classification | 20230712 |
| Device Code Info | Item No. 606-907-001. No UDI-DI (Distributed in Canada and EU). |
| Center Classification Date | 20230703 |
| Recall Initiation Date | 20230523 |
| Recalling Firm | TEI Biosciences, Inc. |
| Initial Notification | Letter |
| Similar To |