Skip to content
Recall Observatory FDA recall evidence

Device product

Restoris MCK Onlay Insert Extractor.

Z-2051-2018

January 19, 2018

Class II

Product summary

Firm
Mako Surgical Corporation
Event
Event 80016
Status
Terminated
Classification
Class II
Quantity
575 units total (400 US, 175 OUS)
Official record key
device-enforcement:Z-2051-2018

Official wording

Reason: Possible hinge pin disassociation from the Mako Onlay Insert Extractor.

Code information: Item No. 160430, Lot No. 19020414, 19090616, 19090915, 19100616, 19100915, 19110317, 19110616, 19110915, 19130315, 19140315, 19451016, 19461016, 19471016, 19490515, 19500515, 19510515, 19520515, 19530515, 26051212, 26070512, 26080913, 26110512, 26120512, 26130512, 26170513, 26201111, 26290412, 26330712, 26340312, 26440912. Expanded scope: Lot No. 19150517, 19160517.

Distribution pattern: Distributed domestically to AL, AR, AZ, CA, CO, CT, FL, IL, IN, KS, LA, MD, MI, MN, MO, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, TN, TX, UT, WI. Distributed internationally to Australia, China, Italy, Netherlands, Singapore, South Africa, Taiwan, Turkey, United Kingdom.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Possible hinge pin disassociation from the Mako Onlay Insert Extractor.