Z-2076-2023 Class II Ongoing
FDA device recall Z-2076-2023 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: 9,215 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
- 9,215 units
Product Description
SurgiMend PRS Meshed; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Size 10cm x 20cm
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. 606-907-001. No UDI-DI (Distributed in Canada and EU).