Reported Oct 15, 2014 · Terminated

MaxLock Extreme Mod-Foot Concave Reamer; Individually packaged in a 3 x 4 bag and heat sealed with label on the…

Orthohelix Surgical Designs Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Orthohelix Surgical Designs Inc · 1065 Medina Rd Ste 500 · Medina, OH · 44256-5376

Is this the product you have?

  • MaxLock Extreme Mod-Foot Concave Reamer; Individually packaged in a 3 x 4 bag and heat sealed with label on the outside. Used during procedures to clear away bone and cartilage within the desired implant area.
Lot codes and dates
  • Part NumberMFT-074-CC-24
  • Lot3164011
Amount recalled
38

Where it was sold

Why it was recalled

Incorrect sizing was being laser etched on the MaxLock Extreme Mod-Foot Concave Reamer

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Oct 31, 2016 · Data as of Sep 19, 6:50 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.