Recall Z-0254-2024— Stryker Corporation

Name: FDA recall Z-0254-2024
Creator: U.S. Food and Drug Administration
Published: 2023-09-11

Class II · Ongoing

Class II FDA medical device recall by Stryker Corporation, initiated 2023-09-11. It names one FDA 510(k) clearance: K121426. Product: Disposable Spetzler-Malis Bipolar forceps, 20CM SLM DISP BAYONET 1.5MM, Catalog Number 6780-200-015. Reason: An error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the product label represents a 54 month (4.5 year) shelf life..

Recalling firm: Stryker Corporation
Classification: Class II
Status: Ongoing
Initiated: 2023-09-11
Firm location: Portage, MI, United States

510(k) clearances named in this recall

1 on FDA's record

K121426 — AYNERGETICS DISPOSABLE SPETZLER-MALIS STANDARD BIPOLAR FORCEPSSynergetics, Inc.·cleared 2012-07-10

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

Disposable Spetzler-Malis Bipolar forceps, 20CM SLM DISP BAYONET 1.5MM, Catalog Number 6780-200-015

Reason for recall

An error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the product label represents a 54 month (4.5 year) shelf life.

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