Z-2077-2023 Class II Ongoing
FDA device recall Z-2077-2023 was initiated by TEI Biosciences, Inc. on May 23, 2023 and is designated Class II. Reason for recall: Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing. The recall status is ongoing. Affected quantity: 4,159 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 12, 2023
- Initiation Date
- May 23, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4,159 units
Product Description
PriMatrix; Dermal Repair Scaffold; Rx Only; Sizes 0.2x26.5 cm (3 pack), 10x12cm, 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, and 8x8 cm.
Reason for Recall
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Distribution Pattern
Domestic: Nationwide Distribution.
Code Information
Item No. (UDI-DI): 607-001-009 (10381780113294), 607-001-112 (10381780113300), 607-001-125 (10381780113317), 607-001-225 (10381780113324), 607-001-440 (10381780113331), 607-001-660 (10381780113348), 607-001-812 (10381780113355), 607-001-880 (10381780113362).