Recall Z-1458-2020 ยท HWC Screw, Fixation, Bone
Nextremity Solutions
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.
| Date | Feb 24, 2020 (initiated Feb 12, 2020) |
| Status | Terminated |
| Reason | 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 |
| Root cause | Under Investigation by firm |
| Action | Nextremity notified European distributors and customers of the FSCA via a Field Safety Notice dated 2/12/2020.The Field Safety Notice instructed return of all product with the specified lot number. |
| Quantity | 190 units |
| Distribution | International distribution in the countries of Spain, United Kingdom, Germany, and Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110445 | FLEXFUSION (TM) FIXATION IMPLANT Nextremity Solutions, LLC, Mar 17, 2011 |