TEI Biosciences, Inc. Recall 92481
Description: PriMatrix Ag Meshed; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm (2:1), 10x25 cm (2:1), 20x25 cm (1:1), 4x4 cm (2:1), 6x6 cm (2:1), 8x12 cm (2:1), 8x8 cm (2:1).
TEI Biosciences, Inc. Recall 92481 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2082-2023 |
| Event ID | 92481 |
| Event Description | PriMatrix Ag Meshed; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm (2:1), 10x25 cm (2:1), 20x25 cm (1:1), 4x4 cm (2:1), 6x6 cm (2:1), 8x12 cm (2:1), 8x8 cm (2:1). |
| Product Type | Devices |
| Distribution | Domestic: Nationwide Distribution. |
| Quantity | 10,159 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. (UDI-DI): 607-105-112 (10381780177685), 607-105-125 (10381780113591), 607-105-225 (10381780113607), 607-105-440 (10381780113614), 607-105-660 (10381780177715), 607-105-812 (10381780177739), 607-105-880 (10381780177722). |
| Center Classification Date | 20230703 |
| Recall Initiation Date | 20230523 |
| Recalling Firm | TEI Biosciences, Inc. |
| Initial Notification | Letter |
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