Z-0910-2022 Class II Terminated
FDA device recall Z-0910-2022 was initiated by Nextremity Solutions on February 10, 2022 and is designated Class II. Reason for recall: Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remove from the proximal Nextra implant, causing delay in surgery The recall status is terminated (terminated October 10, 2024). Affected quantity: 4 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 20, 2022
- Initiation Date
- February 10, 2022
- Termination Date
- October 10, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4 units
Product Description
Nextra Hammertoe Correction System 4.5 Middle 3.2 Proximal Kit SKU: NX-4532K Orthopedic surgical instrument
Reason for Recall
Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remove from the proximal Nextra implant, causing delay in surgery
Distribution Pattern
Distribution US Nationwide, Japan, and the Netherlands
Code Information
Lot Number: 168117318B, 168125017C UDI: 00817701020011