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SurgiMend recallZ-2070-2023 · TEI Biosciences, Inc. · initiated May 23, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from TEI Biosciences, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Under Investigation by firm

What the company is doing

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.

Recall details

Recall number
Z-2070-2023
Status
Open, Classified
Initiated by the company
May 23, 2023
Posted by the FDA
Sep 30, 2024
Recalling firm
TEI Biosciences, Inc.
Quantity
22,163 units
Product code
FTM
FDA submissions
K171357, K071807
Distribution
Domestic: Nationwide Distribution.

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

Code information (models, lots, serial numbers)

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).

Devices named in this recall

14 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

19 devices cleared under K171357, K071807 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 92481).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page