Z-2070-2023Class II

SurgiMend PRS; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x15 cm Semi-Oval, 7x17 cm...

Name: Z-2070-2023 SurgiMend PRS; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x15 cm Semi-Oval, 7x17 cm...
Creator: TEI Biosciences, Inc.
Published: 2023-05-23
License: https://open.fda.gov/license/

Integra LifeSciences Braintree Inc. / initiated 2023-05-23 / Open, Classified / root cause: sterility

FDA source

TEI Biosciences, Inc. began a recall of 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... on 2023-05-23. FDA classified it as Class II and gives the reason as "Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-2070-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-05-23
Posted: 2024-09-30
Recalling firm: Integra LifeSciences Braintree 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
Product code: FTM Mesh, Surgical
Reason for recall: Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Root cause tag: sterility
FDA 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 [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.
Quantity in commerce: 22,163 units
Distribution: Domestic: Nationwide Distribution.
Product codes and lots: 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).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2070-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2069-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-12	2023-07-03
Z-2070-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-12	2023-07-03
Z-2071-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-12	2023-07-03
Z-2072-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-12	2023-07-03
Z-2073-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-12	2023-07-03
Z-2074-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-12	2023-07-03
Z-2075-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-12	2023-07-03
Z-2076-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-12	2023-07-03
Z-2077-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-12	2023-07-03
Z-2078-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-12	2023-07-03
Z-2079-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-12	2023-07-03
Z-2080-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-12	2023-07-03
Z-2081-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-12	2023-07-03
Z-2082-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-12	2023-07-03
Z-2083-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-12	2023-07-03
Z-2084-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-12	2023-07-03
Z-2085-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-12	2023-07-03

Product code FTM

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)