CLASS II Device recall · Reported 20 Apr 2022 · FDA Enforcement Report
Nextra Hammertoe Correction System 5 Middle and 2 Proximal Saw Cut recalled
Nextremity Solutions is recalling Nextra Hammertoe Correction System 5 Middle and 2 Proximal Saw Cut, distributed nationwide in the US. The recall was initiated on 10 Feb 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0913-2022
- FDA event ID
- 89764
- Recalling firm
- Nextremity Solutions, Warsaw, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Feb 2022
- FDA classified
- 12 Apr 2022
- Reported
- 20 Apr 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Device type
- Hip & Knee Implants
Timeline
| 10 Feb 2022 | Recall initiated by company | |
| 12 Apr 2022 | Classified by FDA | +61 days |
| 20 Apr 2022 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Product as listed by the FDA
Nextra Hammertoe Correction System 3.5 Middle and 3.2 Proximal Saw Cut SKU: NX-3532K-SC Orthopedic surgical instrument
Where it was distributed
Distribution US Nationwide, Japan, and the Netherlands
Questions about this recall
Is Nextra Hammertoe Correction System 5 Middle and 2 Proximal Saw Cut recalled?
Yes. Nextremity Solutions recalled Nextra Hammertoe Correction System 5 Middle and 2 Proximal Saw Cut on 10 Feb 2022. The recall is Class II and its status is Terminated. Recall number Z-0913-2022.
Why was it recalled?
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
Which lots are affected?
Lot Number: 168125017B UDI: 00817701020059
Where was it sold?
Distribution US Nationwide, Japan, and the Netherlands
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Nextremity Solutions
All 15| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Nextra Hammertoe Correction System 5 Middle and 2 Proximal Saw Cut recalled | Nextremity Solutions | Other | Nationwide |
| Device | CLASS II | Nextra Hammertoe Correction System 5 Middle 2 Proximal Kit recalled | Nextremity Solutions | Other | Nationwide |
| Device | CLASS II | Nextra Hammertoe Correction System 5 Middle 2 Proximal Kit recalled | Nextremity Solutions | Other | Nationwide |
| Device | CLASS II | Nextra Hammertoe Correction System Driver recalled | Nextremity Solutions | Other | Nationwide |
| Device | CLASS II | Nextra Cannulated Hammertoe Standard Instrument recalled | Nextremity Solutions | Other | Nationwide |
Other Hip & Knee Implants recalls
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|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation | Kico Knee Innovation | Nitrosamine Impurity | 19 states |
| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Lead & Heavy Metals | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |