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
Reported: July 15, 2020 Initiated: June 3, 2020 #Z-2534-2020
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
Details
- Recalling Firm
- Dufner Instrumente GmbH
- Units Affected
- 30 units
- Distribution
- IL
- Location
- Tuttlingen
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Dufner Instrumente GmbH. Units affected: 30 units.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 15, 2020. Severity: Moderate. Recall number: Z-2534-2020.
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