SurgiMend 1.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 18x12 cm Thin and 10x15 cm Thin.
Summary
The FDA issued a Class II for SurgiMend 1.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 18 by TEI Biosciences, Inc.. Reason: Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing..
Details
Source
Device Recall
External ID
Z-2071-2023
Action Date
2023-07-12
Status
Ongoing
Category
device
Product Description
SurgiMend 1.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 18x12 cm Thin and 10x15 cm Thin.
Lot/Code Info: Item No. (UDI-DI): 606-005-003 (10381780112952) and 606-005-004 (10381780112969).
Quantity Affected: 52 units
Reason for Recall
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Distribution
Domestic: Nationwide Distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-05-23
Company
Boston, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 287 device recalls issued in the same week, part of 403 device-related FDA actions this month.
TEI Biosciences, Inc. has 17 FDA actions in our database, including 17 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (TEI Biosciences, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does TEI Biosciences, Inc. have FDA actions?
TEI Biosciences, Inc. has 17 FDA actions in our database, including 17 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2071-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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