Restoris MCK Onlay Insert Extractor.
Hazard
Possible hinge pin disassociation from the Mako Onlay Insert Extractor.
What You Should Do
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.
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Products
- Brand
- Mako Surgical Corporation
- UPC
- 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.
Units Affected
575 units total (400 US, 175 OUS)