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U.S. Department of Health and Human Services

Class 2 Device Recall RIO THA System

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  Class 2 Device Recall RIO THA System see related information
Date Initiated by Firm December 22, 2016
Create Date March 07, 2017
Recall Status1 Open3, Classified
Recall Number Z-1411-2017
Recall Event ID 76158
510(K)Number K121064  K141989  
Product Classification Orthopedic stereotaxic instrument - Product Code OLO
Product MAKO RIO THA Application User Guides, for total hip arthroplasty, orthopedic surgery.
Code Information Part Item #: 204863 - THA 1.0 Application User Guide, Part Item #: 207116 - THA 2.0 Application User Guide, Part Item #: 208692 - THA 2.1 Application User Guide, Part Item #: 209711 - MAKOplasty THA Application User Guide, Part Item #: 210555 - MAKIplast THA 3.1 Application User Guide, Part Item#: 212026 - THA Application User Guide, 2.1-2.1.1, THA 3.0, THA 3.1, 3.1.1 and 3.1.1.1

Part Item # 204863 THA 1.0 Application User Guide, Part Item # 207116 THA 2.0 Application User Guide, Part Item # 208692 THA 2.1 Application User Guide, Part Item # 209711 MAKOplasty THA Application User Guide, Part Item # 210555 MAKIplast THA 3.1 Application User Guide, Part Item # 212026 THA Application User Guide
Recalling Firm/
Manufacturer
Mako Surgical Corporation
2555 Davie Rd Ste 110
Davie FL 33317-7424
For Additional Information Contact
866-647-6256
Manufacturer Reason
for Recall
Five (5) AFMEA Risk Control Measures are missing from the MAKO RIO THA Application User Guides
FDA Determined
Cause 2
Labeling design
Action Letter from Stryker dated 1/28/2017 was sent via USP Next Day Air with return receipt to all their customers. With the following actions; Inform users of this medical device correction and forwar this notice to all those individuals who need to be aware within your organization and return the attached Business Replay Form within 5 business days, to Fax 844-782-5561 or via e-mail to stykerortho4253@stericycle.com
Quantity in Commerce 777
Distribution US nationwide distribution.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = OLO and Original Applicant = MAKO SURGICAL CORPORATION
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