Recall Z-1458-2020— Nextremity Solutions
Class II · Terminated
Class II FDA medical device recall by Nextremity Solutions, initiated 2020-02-12, terminated 2020-12-17. It names one FDA 510(k) clearance: K110445. Product: 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: 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.
- Recalling firm
- Nextremity Solutions
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-02-12
- Terminated
- 2020-12-17
- Firm location
- Warsaw, IN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.