SurgiMend PRS; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x15 cm Semi-Oval,...

FDA Device Recall #Z-2070-2023 — Class II — May 23, 2023

Recall Summary

Recall Number Z-2070-2023
Classification Class II — Moderate risk
Date Initiated May 23, 2023
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm TEI Biosciences, Inc.
Location Boston, MA
Product Type Devices
Quantity 22,163 units

Product Description

SurgiMend PRS; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x15 cm Semi-Oval, 7x17 cm Fenestrated, 10x20 cm Fenestrated, 8x16 cm Semi-Oval, 15x15 cm Semi-Oval, 8x20 cm Fenestrated, 10x15 cm Slant Fenestrated, 7x17 cm Semi-Oval, 8x16 cm Thin Semi-Oval, 10x20 cm Thin Semi-Oval, 6x16 cm Semi-Oval, Thin Oval 8x12 cm, Thin Oval 10x15 cm, Meshed 20cm x 10cm

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.

Lot / Code Information

Item No. (UDI-DI): 606-004-100 (10381780112822), 606-004-101 (10381780112839), 606-004-102 (10381780112846), 606-004-103 (10381780112853), 606-004-104 (10381780112860), 606-004-105 (10381780112877), 606-004-106 (10381780112884), 606-004-107 (10381780112891), 606-004-108 (10381780112907), 606-004-109 (10381780112914), 606-004-110 (10381780112921), 606-005-001 (10381780112938), 606-005-002 (10381780112945), 606-007-001 (10381780357322).

Other Recalls from TEI Biosciences, Inc.

Recall # Classification Product Date
Z-2082-2023 Class II PriMatrix Ag Meshed; Dermal Repair Scaffold; Rx... May 23, 2023
Z-2076-2023 Class II SurgiMend PRS Meshed; Collagen Matrix for Soft ... May 23, 2023
Z-2074-2023 Class II SurgiMend 3.0; Collagen Matrix for Soft Tissue ... May 23, 2023
Z-2071-2023 Class II SurgiMend 1.0; Collagen Matrix for Soft Tissue ... May 23, 2023
Z-2078-2023 Class II PriMatrix Fenestrated; Dermal Repair Scaffold; ... May 23, 2023

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.