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Recall Observatory FDA recall evidence

Device product

Stryker Restoris RIO Reamer Handle, Offset, Mako Rx only Product Usage: The handle is used to hold surgical components during acetabular reaming in MAKO Total Hip procedures.

Z-1193-2017

September 29, 2016

Class II

Product summary

Firm
Mako Surgical Corporation
Event
Event 76025
Status
Terminated
Classification
Class II
Quantity
595 units
Official record key
device-enforcement:Z-1193-2017

Official wording

Reason: Failure of the Offset Cup Reamer Handle not engaging its mating components.

Code information: All lots recalled, Catalog No. 207080.

Distribution pattern: Worldwide Distribution - US Nationwide in the states of AL, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NH, NJ, NM, NY, OH, OK, OR, PA, RI, TN, TX, UT, VA, WA, WI, WV, & WY and the countries of Italy, Germany, Australia, China, Europe, Hong Kong, South Africa, Germany, Thailand & Singapore.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Failure of the Offset Cup Reamer Handle not engaging its mating components.