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Terminated

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.

FDA Recall Z-0062-2015 · Posted 2014-10-10

Recalling FirmOrthohelix Surgical Designs Inc
Recall StatusTerminated
Product CodeLXH
Date Initiated2014-09-19
Date Terminated2016-10-31
Product Quantity38

Reason for Recall

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

Firm Action

An Urgent - Medical Device Recall customer notification, dated September 19, 2014, was sent out via email and FEDEx to all distributors with instructions on returning the product. The letter identified the affected product and the reason for the recall. Customers are to immediately cease distribution of the affected product, and complete and return the questionnaire. The letter also states that the recalled product will be replaced. Questions are to be directed to the Customer Service Department 1-888-494-7950.

Root Cause

Device Design

Distribution Pattern

USA Distribution -- in the states of WI, NM, TX, WA, MO, OH, UT, TN, MI, VA, NC, VA, and PA.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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