Recall Z-2146-2023— Aesculap Implant Systems LLC

Name: FDA recall Z-2146-2023
Creator: U.S. Food and Drug Administration
Published: 2023-05-18

Class II · Ongoing

Class II FDA medical device recall by Aesculap Implant Systems LLC, initiated 2023-05-18. FDA's recall record names no specific 510(k) clearance for this event. Product: Aesculap Surgical Needle, straight, 3 1/2", (90 mm), 13GA, width: 2,400 mm, non-sterile, reusable Article Number: MD610. Reason: Incorrect product code marked on the product, etched with product code MD611, however; the correct product code is MD610..

Recalling firm: Aesculap Implant Systems LLC
Classification: Class II
Status: Ongoing
Initiated: 2023-05-18
Firm location: Center Valley, PA, United States

Product description

Aesculap Surgical Needle, straight, 3 1/2", (90 mm), 13GA, width: 2,400 mm, non-sterile, reusable Article Number: MD610

Reason for recall

Incorrect product code marked on the product, etched with product code MD611, however; the correct product code is MD610.

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