CLASS II Device recall · Reported 16 Mar 2022 · FDA Enforcement Report
Nextra CH Cannulated Hammertoe Mini Instrument recalled
Nextremity Solutions is recalling Nextra CH Cannulated Hammertoe Mini Instrument Kit-indicated for small bone, distributed nationwide in the US. The recall was initiated on 13 Jan 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-0739-2022
- FDA event ID
- 89588
- Recalling firm
- Nextremity Solutions, Warsaw, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 Jan 2022
- FDA classified
- 9 Mar 2022
- Reported
- 16 Mar 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 13 Jan 2022 | Recall initiated by company | |
| 9 Mar 2022 | Classified by FDA | +55 days |
| 16 Mar 2022 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
During insertion of the middle phalanx implant into bone, the driver may deform the implant locking mechanism and result in inadequate mating force between the middle and proximal phalanx implants, resulting in surgical delay, in-situ removal of the implant, use of alternative surgical approach, disassembly of the implants post-operatively, and revision
Product as listed by the FDA
Nextra CH Cannulated Hammertoe Mini Instrument Kit-indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toes SKU: CH-MINI-KT
Where it was distributed
US Nationwide distribution in the states of AZ, IL, GA, LA, MD, NY, PA, TX, WA.
Nationwide ArizonaGeorgiaIllinoisLouisianaMarylandNew YorkPennsylvaniaTexasWashington
Stores named: Walmart
Questions about this recall
Is Nextra CH Cannulated Hammertoe Mini Instrument Kit-indicated for small bone recalled?
Yes. Nextremity Solutions recalled Nextra CH Cannulated Hammertoe Mini Instrument Kit-indicated for small bone on 13 Jan 2022. The recall is Class II and its status is Terminated. Recall number Z-0739-2022.
Why was it recalled?
During insertion of the middle phalanx implant into bone, the driver may deform the implant locking mechanism and result in inadequate mating force between the middle and proximal phalanx implants, resulting in surgical delay, in-situ removal of the implant, use of alternative surgical approach, disassembly of the implants post-operatively, and revision
Which lots are affected?
Lot Number: 1578401 UDI: 00817701026389
Where was it sold?
US Nationwide distribution in the states of AZ, IL, GA, LA, MD, NY, PA, TX, WA.
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 Hammertoe Correction System 5 Middle and 2 Proximal Saw Cut recalled | Nextremity Solutions | Other | Nationwide |
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