Mako Surgical Corporation: Medical Device Recall in 2018 - (Recall #: Z-2051-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Restoris MCK Onlay Insert Extractor.

Product Classification:

Class II

Date Initiated: January 19, 2018

Date Posted: June 13, 2018

Recall Number: Z-2051-2018

Event ID: 80016

Reason for Recall:

Possible hinge pin disassociation from the Mako Onlay Insert Extractor.

Status: Terminated

Product Quantity: 575 units total (400 US, 175 OUS)

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.

Voluntary or Mandated:

Voluntary: Firm initiated