Z-0913-2022Class II

Nextra Hammertoe Correction System 3.5 Middle and 3.2 Proximal Saw Cut SKU: NX-3532K-SC Orthopedic surgical...

Name: Z-0913-2022 Nextra Hammertoe Correction System 3.5 Middle and 3.2 Proximal Saw Cut SKU: NX-3532K-SC Orthopedic surgical...
Creator: Nextremity Solutions
Published: 2022-02-10
License: https://open.fda.gov/license/

Medartis AG / initiated 2022-02-10 / Terminated / root cause: manufacturing process

FDA source

Nextremity Solutions began a recall of Nextra Hammertoe Correction System 3.5 Middle and 3.2 Proximal Saw Cut SKU: NX-3532K-SC Orthopedic surgical instrument on 2022-02-10. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0913-2022
Classification: Class II
Status: Terminated
Initiated: 2022-02-10
Posted: 2022-04-12
Terminated: 2024-10-10
Recalling firm: Medartis AG
Product: Nextra Hammertoe Correction System 3.5 Middle and 3.2 Proximal Saw Cut SKU: NX-3532K-SC Orthopedic surgical instrument
Product code: HWC Screw, Fixation, Bone
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
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Nextremity Solutions issued Urgent Medical Device Recall letter on 2/10/22 via mail and email to Distributors and Risk Mangers. Nextremity Solutions products with the referenced part and lot number should not be used and should be quarantined and returned to Zimmer Biomet for return to Nextremity Solutions. If you have affected product at your facility, locate and quarantine affected product in your inventory. Zimmer Biomet Sales representative will remove the affected product from your facility. Complete Medical Device Recall Return Response and send to [email protected], even if you do not have affected products at your facility. If you have further questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Or email to [email protected].
Quantity in commerce: 89 units
Distribution: Distribution US Nationwide, Japan, and the Netherlands
Product codes and lots: Lot Number: 168125017B UDI: 00817701020059

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0913-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0910-2022	Class II	Terminated	Voluntary: Firm initiated	2022-04-20	2022-04-12
Z-0911-2022	Class II	Terminated	Voluntary: Firm initiated	2022-04-20	2022-04-12
Z-0912-2022	Class II	Terminated	Voluntary: Firm initiated	2022-04-20	2022-04-12
Z-0913-2022	Class II	Terminated	Voluntary: Firm initiated	2022-04-20	2022-04-12
Z-0914-2022	Class II	Terminated	Voluntary: Firm initiated	2022-04-20	2022-04-12

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)