Z-1458-2020Class II

Nextra Hammertoe Correction System-4.5MM Middle, 3.2MM Proximal, SS, Sterile. REF: NX-4532K -

Name: Z-1458-2020 Nextra Hammertoe Correction System-4.5MM Middle, 3.2MM Proximal, SS, Sterile. REF: NX-4532K -
Creator: Nextremity Solutions
Published: 2020-02-12
License: https://open.fda.gov/license/

Medartis AG / initiated 2020-02-12 / Terminated

FDA source

Nextremity Solutions began a recall of 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... on 2020-02-12. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1458-2020
Classification: Class II
Status: Terminated
Initiated: 2020-02-12
Posted: 2020-02-24
Terminated: 2020-12-17
Recalling firm: Medartis AG
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.
Product code: HWC Screw, Fixation, Bone
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
FDA 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 in commerce: 190 units
Distribution: International distribution in the countries of Spain, United Kingdom, Germany, and Switzerland.
Product codes and lots: Lot Number: 168117318B UDI: 00817701020011

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1458-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1458-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-18	2020-03-09

Product code HWC

K110445Class IIFlexfusion (Tm) Fixation ImplantNextremity Solutions, LLC / cleared 2011-03-17

China's FDA-registered implant bench is 151 establishments of 4,70415 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)