CLASS II ONGOING Device recall · Reported 4 Sep 2024 · FDA Enforcement Report
Nanoplasty 3D Bunion Correction System Implant recalled
Treace Medical Concepts is recalling Nanoplasty 3D Bunion Correction System Implant, distributed nationwide in the US. The recall was initiated on 2 Jun 2024 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-2718-2024
- FDA event ID
- 94977
- Recalling firm
- Treace Medical Concepts, Ponte Vedra, FL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 2 Jun 2024
- FDA classified
- 23 Aug 2024
- Reported
- 4 Sep 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 2 Jun 2024 | Recall initiated by company | |
| 23 Aug 2024 | Classified by FDA | +82 days |
| 4 Sep 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential issue causing a higher frequency of interference with locking screws and/or inserter rods than anticipated, resulting in screws stripping and/or not fully seating in the plates and/or interface issues between inserter rods and plates.
Product as listed by the FDA
Nanoplasty 3D Bunion Correction System Implant, Model Number: SK57. System contains the 01-00066 1st Metatarsal Plate as a component.
Where it was distributed
US Nationwide distribution in the states of CO, FL, MD, MI, NC, SC, TX, VA.
Nationwide ColoradoFloridaMarylandMichiganNorth CarolinaSouth CarolinaTexasVirginia
Questions about this recall
Why was it recalled?
Potential issue causing a higher frequency of interference with locking screws and/or inserter rods than anticipated, resulting in screws stripping and/or not fully seating in the plates and/or interface issues between inserter rods and plates.
Which lots are affected?
UDI: (01)00810111222464(17)290424(10)300542404
Where was it sold?
US Nationwide distribution in the states of CO, FL, MD, MI, NC, SC, TX, VA.
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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