Treace Medical recalls Nanoplasty 3D Bunion Correction System Implant Model SK57 due to potential screw stripping and interface issues. Affected users should contact for remedy.
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.
Treace Medical is recalling their Nanoplasty 3D Bunion Correction System Implant (Model SK57) because it may cause screws to strip or not seat properly, leading to interface problems. This could affect the implant's stability and effectiveness.
The implant's locking screws and inserter rods may strip or not seat properly, causing interface issues between the rods and plates. This could lead to instability in the correction system.
People who purchased the Nanoplasty 3D Bunion Correction System Implant (Model SK5: 01-00066 1st Metatarsal Plate) for bunion correction are likely affected. Those with the implant are at risk of interface issues if screws strip.
Check for the model number SK57 on the implant packaging or label. The system includes the 01-00066 1st Metatarsal Plate as a component.
Reach out to Treace Medical for guidance on the recall and next steps.
The recall indicates potential issues with screw seating and interface, but the hazard is not severe enough to require immediate stop-use.
Check for the model number SK57 on the implant packaging or label. The system includes the 01-00066 1st Metatarsal Plate as a component.
Contact Treace Medical for guidance on the recall and next steps.
We’ve drafted a message you can send Treace Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2718-2024 — Treace Medical Treace Medical Hello, I own a Treace Medical that is covered by recall Z-2718-2024 from Treace Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
