Restoris MCK Onlay Insert Extractor.
This recall has been terminated (originally issued June 1, 2018).
- Company
- Mako Surgical Corporation
- Recall Initiated
- January 19, 2018
- Posted
- June 1, 2018
- Terminated
- September 16, 2020
- Recall Number
- Z-2051-2018
- Quantity
- 575 units total (400 US, 175 OUS)
- Firm Location
- Davie, FL
- Official Source
- View on FDA website ↗
Reason for Recall
Possible hinge pin disassociation from the Mako Onlay Insert Extractor.
Distribution
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.
Lot / Code Info
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.
Root Cause
Under Investigation by firm
Action Taken
Customers were initially notified on approximately 01/19/2018, and again notified when the recall was expanded on 04/25/2018. Instructions included to inform all applicable individuals within the organization that need to be notified, complete and return the Recall Notification Business Reply Form, and make arrangements for return all affected products on hand. On about 12/12/2018, Stryker expanded the scope of the recall to include two additional lot codes and notified customers via "URGENT MEDICAL DEVICE REMOVAL" letter. Instructions were the same as the original recall notification.