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U.S. Department of Health and Human Services

Class 2 Device Recall MAKOplasty Hip Array Kit Laminate

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  Class 2 Device Recall MAKOplasty Hip Array Kit Laminate see related information
Date Initiated by Firm November 25, 2015
Create Date April 29, 2016
Recall Status1 Terminated 3 on August 25, 2016
Recall Number Z-1588-2016
Recall Event ID 73199
510(K)Number K121064  
Product Classification Orthopedic stereotaxic instrument - Product Code OLO
Product MAKOplasty Hip Array Kit Laminate 150230
Code Information Catalog No. 210540, Lot Code: 150324
Recalling Firm/
Manufacturer		 Mako Surgical Corporation
2555 Davie Rd Ste 110
Plantation FL 33317-7424
For Additional Information Contact Clayton Odor
866-647-6256
Manufacturer Reason
for Recall		 Stryker Orthpaedics became aware that there is the potential for the 210540 MAKOplasty Hip Array Kit Laminate 150230 to list two part numbers for the RIO Base Array, which is item #5 on the product table.
FDA Determined
Cause 2		 Component change control
Action On 12/09/2015, Product Field Action Letters and Product Accountability forms were sent to Branch/Agencies via overnight courier with a return receipt; Hospital Risk Management were sent Notification letters and a Product Recall Acknowledgement form with return receipt on 12/9;/2015.
Quantity in Commerce 10 units.
Distribution CO, KY, MN, WA and WV
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 = OLO and Original Applicant = MAKO SURGICAL CORPORATION
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