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U.S. Department of Health and Human Services

Class 2 Device Recall Restoris MCK Onlay Insert Extractor

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  Class 2 Device Recall Restoris MCK Onlay Insert Extractor see related information
Date Initiated by Firm January 19, 2018
Date Posted June 01, 2018
Recall Status1 Terminated 3 on September 16, 2020
Recall Number Z-2051-2018
Recall Event ID 80016
510(K)Number K090763  
Product Classification Prosthesis, knee patellofemorotibial, partial, semi-constrained, cemented, polymer/metal/polymer - Product Code NPJ
Product Restoris MCK 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.
Recalling Firm/
Manufacturer		 Mako Surgical Corporation
2555 Davie Rd Ste 110
Davie FL 33317-7424
For Additional Information Contact Bethany Hinson
954-628-0598
Manufacturer Reason
for Recall		 Possible hinge pin disassociation from the Mako Onlay Insert Extractor.
FDA Determined
Cause 2		 Under Investigation by firm
Action 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.
Quantity in Commerce 575 units total (400 US, 175 OUS)
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = NPJ and Original Applicant = MAKO SURGICAL CORPORATION
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