FDA recall Z-2146-2023

Aesculap Implant Systems LLC · Class II · device

Product

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.

Distribution

US Nationwide distribution in the states of DC, MO, PA, TX.

Key facts

Status
Ongoing
Initiation date
2023-05-18
Report date
2023-07-26
Voluntary/Mandated
Voluntary: Firm initiated
Location
Center Valley, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2146-2023