SurgiMend; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 1.0 5x6 cm, 1.0 6x12 cm, 1.0 10x10 cm, 1.0 10x

FDA device recall Z-2069-2023 · posted 2024-09-30 · Open, Classified

Recall details

Recalling firm

TEI Biosciences, Inc.

Reason for recall

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

Action taken

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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

FTM

Quantity affected

14,535 units

Distribution

Domestic: Nationwide Distribution.

Date initiated

2023-05-23

Date posted

2024-09-30

Location

Boston, MA

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