FDA Recall Open, Classified

SurgiMend; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 1.0 5x6 cm, 1.0 6x12 cm, 1.0 10x10 cm, 1.0 10x15 cm, 1.0 10x20 cm, 1.0 16x20 cm, 1.0 13x25 cm, 1.0 4x16 cm, 1.0 3x3 cm, 1.0 4x7 cm, 1.0 4x12 cm, 1.0 6x16 cm, 1.0 25x40 cm, 1.0 20 x 30 cm, 1.0 8x16 cm, 1.0 4x7 cm Thin, 1.0 5x6 cm Thin, 1.0 3x3 cm Thin, 1.0 0.3x25 cm, 1.0 0.6x25 cm, 1.0 1x25 cm.

Recall: Z-2069-2023 · Initiated May 23, 2023

Recall

Recall Number: Z-2069-2023
Event Number: 92481
Firm: TEI Biosciences, Inc.
FEI Number: 3004170064
Product Code: FTM
Status: Open, Classified
Root Cause: Under Investigation by firm
Initiated: May 23, 2023
Posted: September 30, 2024
Address: 7 Elkins St, Boston, MA, 02127-1601

Description

Reason

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

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 [email protected] 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.

Distribution

Domestic: Nationwide Distribution.

Quantity

14,535 units