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).
Reported: July 12, 2023 Initiated: May 23, 2023 #Z-2082-2023
Product 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).
Reason for Recall
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Details
- Recalling Firm
- TEI Biosciences, Inc.
- Units Affected
- 10,159 units
- Distribution
- Domestic: Nationwide Distribution.
- Location
- Boston, MA
Frequently Asked Questions
What product was recalled? ▼
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).. Recalled by TEI Biosciences, Inc.. Units affected: 10,159 units.
Why was this product recalled? ▼
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 12, 2023. Severity: Moderate. Recall number: Z-2082-2023.
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