Revize; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x10 cm, 4x12 cm, 4x16 cm.
Reported: July 12, 2023 Initiated: May 23, 2023 #Z-2083-2023
Product Description
Revize; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x10 cm, 4x12 cm, 4x16 cm.
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
- 199 units
- Distribution
- Domestic: Nationwide Distribution.
- Location
- Boston, MA
Frequently Asked Questions
What product was recalled? ▼
Revize; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x10 cm, 4x12 cm, 4x16 cm.. Recalled by TEI Biosciences, Inc.. Units affected: 199 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-2083-2023.
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