Recall Z-0912-2022— Nextremity Solutions

Name: FDA recall Z-0912-2022
Creator: U.S. Food and Drug Administration
Published: 2022-02-10

Class II · Terminated

Class II FDA medical device recall by Nextremity Solutions, initiated 2022-02-10, terminated 2024-10-10. It names one FDA 510(k) clearance: K110445. Product: Nextra Hammertoe Correction System 3.5 Middle 3.2 Proximal Kit SKU: NX-3532K Orthopedic surgical instrument. Reason: 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.

Recalling firm: Nextremity Solutions
Classification: Class II
Status: Terminated
Initiated: 2022-02-10
Terminated: 2024-10-10
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K110445 — FLEXFUSION (TM) FIXATION IMPLANTNextremity Solutions, LLC·cleared 2011-03-17

K-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 3.5 Middle 3.2 Proximal Kit SKU: NX-3532K 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

Data sourced from openFDA. This site is unofficial and independent of the FDA.