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Z-0062-2015 Class II Terminated

Recalled by Orthohelix Surgical Designs Inc — Medina, OH

FDA device recall Z-0062-2015 was initiated by Orthohelix Surgical Designs Inc on September 19, 2014 and is designated Class II. Reason for recall: Incorrect sizing was being laser etched on the MaxLock Extreme Mod-Foot Concave Reamer The recall status is terminated (terminated October 31, 2016). Affected quantity: 38.

Recall Details

Product Type: Devices
Report Date: October 15, 2014
Initiation Date: September 19, 2014
Termination Date: October 31, 2016
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 38

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.

Reason for Recall

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

Distribution Pattern

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

Code Information

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