Z-2146-2023 Class II Ongoing
FDA device recall Z-2146-2023 was initiated by Aesculap Implant Systems LLC on May 18, 2023 and is designated Class II. Reason for recall: Incorrect product code marked on the product, etched with product code MD611, however; the correct product code is MD610. The recall status is ongoing. Affected quantity: 7 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 26, 2023
- Initiation Date
- May 18, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7 units
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.
Distribution Pattern
US Nationwide distribution in the states of DC, MO, PA, TX.
Code Information
GUIDID: 04046963469054 Lot Number: 22002834