Z-1458-2020 Class II Terminated
FDA device recall Z-1458-2020 was initiated by Nextremity Solutions on February 12, 2020 and is designated Class II. Reason for recall: Proximal end of the driver in the affected product may be oversized in varying degrees, potentially making it difficult to connect with and remove from the proximal Nextra implant The recall status is terminated (terminated December 17, 2020). Affected quantity: 190 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 18, 2020
- Initiation Date
- February 12, 2020
- Termination Date
- December 17, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 190 units
Product Description
Nextra Hammertoe Correction System-4.5MM Middle, 3.2MM Proximal, SS, Sterile. REF: NX-4532K - Product Usage: The Nextra Hammertoe Correction System is a system of implants and associated instruments which is indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toes.
Reason for Recall
Proximal end of the driver in the affected product may be oversized in varying degrees, potentially making it difficult to connect with and remove from the proximal Nextra implant
Distribution Pattern
International distribution in the countries of Spain, United Kingdom, Germany, and Switzerland.
Code Information
Lot Number: 168117318B UDI: 00817701020011