Recall Z-0909-2023— Integra LifeSciences Corp.

Name: FDA recall Z-0909-2023
Creator: U.S. Food and Drug Administration
Published: 2022-12-02

Class II · Ongoing

Class II FDA medical device recall by Integra LifeSciences Corp., initiated 2022-12-02. It names one FDA 510(k) clearance: K193346. Product: Codman Surgical Patties, Part number 801400; SURG PATXRAY 1/2X1/2-200; Lot 6396457. Reason: Integra LifeSciences identified that one lot was released with out-of-specification endotoxin results. The worst-case risk for the use of affected Surgical Patties is potentially a minor transient fever..

Recalling firm: Integra LifeSciences Corp.
Classification: Class II
Status: Ongoing
Initiated: 2022-12-02
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

Codman Surgical Patties, Part number 801400; SURG PATXRAY 1/2X1/2-200; Lot 6396457

Reason for recall

Integra LifeSciences identified that one lot was released with out-of-specification endotoxin results. The worst-case risk for the use of affected Surgical Patties is potentially a minor transient fever.

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