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U.S. Department of Health and Human Services

Class 2 Device Recall Offset Cup Reamer Handle

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  Class 2 Device Recall Offset Cup Reamer Handle see related information
Date Initiated by Firm September 29, 2016
Create Date February 11, 2017
Recall Status1 Open3, Classified
Recall Number Z-1193-2017
Recall Event ID 76025
510(K)Number K121064  
Product Classification Orthopedic stereotaxic instrument - Product Code OLO
Product Stryker Restoris RIO Reamer Handle, Offset, Mako Rx only

Product Usage:
The handle is used to hold surgical components during acetabular reaming in MAKO Total Hip procedures.
Code Information All lots recalled, Catalog No. 207080.
Recalling Firm/
Manufacturer
Mako Surgical Corporation
2555 Davie Rd Ste 110
Davie FL 33317-7424
For Additional Information Contact Clayton Odor
954-628-0502
Manufacturer Reason
for Recall
Failure of the Offset Cup Reamer Handle not engaging its mating components.
FDA Determined
Cause 2
Component change control
Action Customers were sent a recall notificaiton letter, dated 10/17/2016, addressing the reason for recall and the appropriate actions that should be taken by customers. Consignees are instructed to return any recalled product on hand to Stryker C/O Stericycle, 2670 Executive Dr. Suite A, Indianapolis, IN 46241, Attn RA 2016-083, RA 2016-119 - Event 8811. Consignees are also instructed to inform their users of this recall and forward the notice to affected individuals. A Business Reply Form was provided and is to be completed within 5 business days of receipt by consignees. Completed business reply forms are to be faxed to 855-620-5693 or emailed to strykerortho8811@stericycle.com.
Quantity in Commerce 595 units
Distribution Worldwide Distribution - US Nationwide in the states of AL, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NH, NJ, NM, NY, OH, OK, OR, PA, RI, TN, TX, UT, VA, WA, WI, WV, & WY and the countries of Italy, Germany, Australia, China, Europe, Hong Kong, South Africa, Germany, Thailand & Singapore.
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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