TEI Biosciences, Inc.: 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

Recall number

Z-2070-2023

Recalling firm

TEI Biosciences, Inc.

Product

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

Status

Open, Classified

Initiated

2023-05-23

Posted

2024-09-30

Terminated

not on file

Reason

Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.

Root cause

Under Investigation by firm

Action

The firm sent recall notifications to customers via email on 5/23/2023 and by mail on 5/24/2023. The recall notification informs customers that Integra is conducting a removal of all Surgimend PRS, Surgimend PRS Meshed, Surgimend, Surgimend MP, Revize, Revize-X, PriMatrix Dermal Repair Scaffold, and PriMatrix AG Antimicrobial Dermal Repair Scaffold devices due to identified issues with in-process and finished goods endotoxin testing that may result in out of specification endotoxin results. Customers are to check their stock for any lot of products listed in the provided Appendix and immediately remove them from service. All customers are asked to complete the provided acknowledgement form, regardless if affected product is on hand, and return it by email to Integralife6562@sedgwick.com or by fax to 888-229-0320. Questions about the acknowledgement form can be directed to 888-656-6375. Customers are to keep a copy of the recall notice for their records. A prepaid shipping label has been provided to all consignees so that return of products may be facilitated. Returns are being accepted for credit, however if a refund is preferred the firm asks that thsi is indicated in the "special instructions" section of the acknowledgement form. If any affected devices have been implanted, customers are to monitor the patient for a fever in the immediate postoperative period according to the standard hospital or clinician protocol. Customers with any questions can reach out to their Integra Sales Representative or Customer Service at 1-800-654-2873.

Quantity

22,163 units

Distribution

Domestic: Nationwide Distribution.

Lot, serial or model codes

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).

510(k) numbers

["K171357","K071807"]

PMA numbers

not on file

Product code

FTM

Firm FEI

3004170064

Firm city

Boston

Firm state

MA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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