Orthohelix Surgical Designs Inc: Medical Device Recall in 2014 - (Recall #: Z-0062-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: September 19, 2014

Date Posted: October 15, 2014

Recall Number: Z-0062-2015

Event ID: 69294

Reason for Recall:

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

Status: Terminated

Product Quantity: 38

Code Information:

Part Number: MFT-074-CC-24; Lot: 3164011

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated