MaxLock Extreme Mod-Foot Concave Reamer; Individually packaged in a 3 x 4 bag and heat sealed with label on the outside. Used during p...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0062-2015.
Incorrect sizing was being laser etched on the MaxLock Extreme Mod-Foot Concave Reamer
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0062-2015.
Recall terminated by FDA.
✅ 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 Orthohelix Surgical Designs 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-0062-2015.
Orthohelix Surgical Designs Inc
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The FDA regulates drugs, medical devices, food, cosmetics, and tobacco. Adverse event reports and recall notices are the main public safety signal.
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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.
Orthohelix Surgical Designs Inc Recall FAQ
Orthohelix Surgical Designs Inc is the subject of a medical implants safety report: MaxLock Extreme Mod-Foot Concave Reamer; Individually packaged in a 3 x 4 bag and heat sealed with label on the outside. Used during p.... The notice was published on September 19, 2014 by the U.S. Food and Drug Administration (FDA). Approximately 38 units are potentially affected.