Z-2084-2023 Class II Ongoing
FDA device recall Z-2084-2023 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: 665 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
- 665 units
Product Description
Revize-X; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 12x6 cm and 10x9 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): 611-005-001 (10381780357308), 611-005-002 (10381780357315).