Z-2051-2018 Class II Terminated
FDA device recall Z-2051-2018 was initiated by Mako Surgical Corporation on January 19, 2018 and is designated Class II. Reason for recall: Possible hinge pin disassociation from the Mako Onlay Insert Extractor. The recall status is terminated (terminated September 16, 2020). Affected quantity: 575 units total (400 US, 175 OUS).
Recall Details
- Product Type
- Devices
- Report Date
- June 13, 2018
- Initiation Date
- January 19, 2018
- Termination Date
- September 16, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 575 units total (400 US, 175 OUS)
Product Description
Restoris MCK Onlay Insert Extractor.
Reason for Recall
Possible hinge pin disassociation from the Mako Onlay Insert Extractor.
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.
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.