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

FDA device recall Z-0062-2015 · posted 2014-10-10 · Terminated

Recall details

Recalling firm

Orthohelix Surgical Designs Inc

Reason for recall

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

Action taken

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

Status

Terminated

Product code

LXH

Quantity affected

38

Distribution

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

Date initiated

2014-09-19

Date posted

2014-10-10

Date terminated

2016-10-31

Location

Medina, OH