PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: March 18, 2020 Initiated: February 12, 2020 #Z-1458-2020

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

Details

Recalling Firm
Nextremity Solutions
Units Affected
190 units
Distribution
International distribution in the countries of Spain, United Kingdom, Germany, and Switzerland.
Location
Warsaw, IN

Frequently Asked Questions

What product was recalled?
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.. Recalled by Nextremity Solutions. Units affected: 190 units.
Why was this product recalled?
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
Which agency issued this recall?
This recall was issued by the FDA Devices on March 18, 2020. Severity: Moderate. Recall number: Z-1458-2020.