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Recall Observatory FDA recall evidence

Device product

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.

Z-0062-2015

September 19, 2014

Class II

Product summary

Firm
Orthohelix Surgical Designs Inc
Event
Event 69294
Status
Terminated
Classification
Class II
Quantity
38
Official record key
device-enforcement:Z-0062-2015

Official wording

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

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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