High RiskFDAfda-Z-2718-2024OTHER

Nanoplasty 3D Bunion Correction System Implant, Model Number: SK57. System contains the 01-00066 1st Metatarsal Plate as a component.

Q: What is being recalled?

Treace Medical Concepts, Inc. is the subject of a medical implants safety report: Nanoplasty 3D Bunion Correction System Implant, Model Number: SK57. System contains the 01-00066 1st Metatarsal Plate as a component.. The notice was published on June 2, 2024 by the U.S. Food and Drug Administration (FDA). Approximately 40 units are potentially affected.

Q: Why was this product recalled?

This recall was issued in connection with a other concern. The full description above contains the FDA's official wording about the defect, affected lots, and impacted distribution — read it carefully.

Q: What should I do if I have this product?

Stop using the product. Check the lot number, model number, or sell-by date against the recall notice above. Then contact Treace Medical Concepts, Inc. or the retailer where you purchased it to request a refund, replacement, or repair. The official FDA page has the most current instructions: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts.

Q: Is a refund or replacement free?

Yes. Under federal recall procedures, consumers are entitled to a remedy at no cost — typically a full refund, free replacement, or free repair. There is generally no expiration on safety recalls. Keep your receipt if possible, but most agencies require remedies even without proof of purchase.

Q: Has anyone been hurt by this product?

Injury and incident reports are part of the official recall announcement above. If you or a member of your household has been harmed by this product, report the incident to FDA at https://www.fda.gov/safety/report-problem-fda. Reports help the agency identify ongoing risks and pursue follow-up enforcement.

Q: Where can I get more information?

The U.S. Food and Drug Administration (FDA) is the authoritative source for this recall. Visit https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts for the complete recall notice, lot codes, and the manufacturer's contact information.

Q: Is this an FDA food or cosmetic recall?

This recall is in the FDA's jurisdiction and may cover food, dietary supplements, cosmetics, or related products. Follow the FDA's official guidance in the notice above. If you have consumed the product and are concerned about your health, contact a healthcare provider.

Brand

Treace Medical Concepts, Inc.

FDA Recall Notice

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2718-2024.

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.

Corrective Action (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2718-2024.

Recall ongoing. Follow firm instructions.

✅ What you should do

Stop using the product if you own it.
Check the model number, lot code, or sell-by date against the recall notice above.
Contact Treace Medical Concepts, Inc. or the retailer where you bought it for a refund, replacement, or repair.
For the most current official instructions, visit the FDA recall page.
If you've been hurt by this product, report the incident to FDA.

Consumer Contact (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2718-2024.

Treace Medical Concepts, Inc.

Official Source

FDA Recalls

U.S. Food and Drug Administration

Report an Incident

File a Complaint

Reports inform future enforcement

About the U.S. Food and Drug Administration

The FDA regulates drugs, medical devices, food, cosmetics, and tobacco. Adverse event reports and recall notices are the main public safety signal.

Visit FDA.gov →

📣 Report a food, supplement, or cosmetic problem to the FDA

If you had a reaction, found contamination, or experienced a labeling problem with this product, report it to the FDA. The agency uses consumer reports to track emerging safety signals and trigger recalls.

How to report to FDA →File a report at FDA →

Treace Medical Concepts, Inc. Recall FAQ

What is being recalled?

Treace Medical Concepts, Inc. is the subject of a medical implants safety report: Nanoplasty 3D Bunion Correction System Implant, Model Number: SK57. System contains the 01-00066 1st Metatarsal Plate as a component.. The notice was published on June 2, 2024 by the U.S. Food and Drug Administration (FDA). Approximately 40 units are potentially affected.

Why was this product recalled?

What should I do if I have this product?

Is a refund or replacement free?

Has anyone been hurt by this product?

Where can I get more information?

Is this an FDA food or cosmetic recall?

Nanoplasty 3D Bunion Correction System Implant, Model Number: SK57. System contains the 01-00066 1st Metatarsal Plate as a component.

FDA Recall Notice

Corrective Action (per FDA)

✅ What you should do

Consumer Contact (per FDA)

About the U.S. Food and Drug Administration

📣 Report a food, supplement, or cosmetic problem to the FDA

Treace Medical Concepts, Inc. Recall FAQ

Other medical implants recalls