Recall Z-2077-2023— TEI Biosciences, Inc.
Class II · Ongoing
Class II FDA medical device recall by TEI Biosciences, Inc., initiated 2023-05-23. It names one FDA 510(k) clearance: K153690. Product: 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: Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing..
- Recalling firm
- TEI Biosciences, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-05-23
- Firm location
- Boston, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.