Z-2534-2020 Class II Terminated
FDA device recall Z-2534-2020 was initiated by Dufner Instrumente GmbH on June 3, 2020 and is designated Class II. Reason for recall: Tungsten carbide plate, which is intended to hold the sewing needle securely, can break when holding the sewing needle under pressure and result in in patient tissue injury The recall status is terminated (terminated January 21, 2021). Affected quantity: 30 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 15, 2020
- Initiation Date
- June 3, 2020
- Termination Date
- January 21, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 30 units
Product Description
DUFNER Instrumente GmbH-De Bakey Slim Needleholder- intended to hold a suturing needle for closing wounds during suturing and surgical procedures Reference Number: 18044-23
Reason for Recall
Tungsten carbide plate, which is intended to hold the sewing needle securely, can break when holding the sewing needle under pressure and result in in patient tissue injury
Distribution Pattern
IL
Code Information
Lot Numbers: 8170368 and 8180673