Recall Z-0237-2025— Integra LifeSciences Corp.

Name: FDA recall Z-0237-2025
Creator: U.S. Food and Drug Administration
Published: 2024-09-20

Class II · Ongoing

Class II FDA medical device recall by Integra LifeSciences Corp., initiated 2024-09-20. It names one FDA 510(k) clearance: K193346. Product: SURG PAT XRAY 1/4X3 Model/Catalog Number: 801398. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.. Reason: Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods.

Recalling firm: Integra LifeSciences Corp.
Classification: Class II
Status: Ongoing
Initiated: 2024-09-20
Firm location: Princeton, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K193346 — Codman Surgical Patties & StripsIntegra LifeSciences Corporation·cleared 2020-11-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

SURG PAT XRAY 1/4X3 Model/Catalog Number: 801398. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.

Reason for recall

Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods

Data sourced from openFDA. This site is unofficial and independent of the FDA.