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U.S. Department of Health and Human Services

Class 2 Device Recall RESTORIS MCK TIBIAL BASEPLATE

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  Class 2 Device Recall RESTORIS MCK TIBIAL BASEPLATE see related information
Date Initiated by Firm December 01, 2017
Create Date May 04, 2018
Recall Status1 Open3, Classified
Recall Number Z-1644-2018
Recall Event ID 79585
510(K)Number K170891  K170584  
Product Classification Orthopedic stereotaxic instrument - Product Code OLO
Product RESTORIS MCK TIBIAL BASEPLATE-RM/LL used in unicompartmental knee arthroplasty and knee replacements.
Code Information Size 2 Item # 180612 Lot # 26080317-01 and  Size 7 Item # 180617 Lot # 26150217-01.  
Recalling Firm/
Manufacturer
Mako Surgical Corporation
2555 Davie Rd Ste 110
Davie FL 33317-7424
For Additional Information Contact
954-628-7000
Manufacturer Reason
for Recall
Incorrect product and/or label. Sizing is labeled incorrectly.
FDA Determined
Cause 2
Error in labeling
Action An URGENT MEDICAL DEVICE RECALL was sent on December 05, 2017 Product Field Action #: 1658081 Description: MCK TIBIAL BASEPLATE-RM/LL-SZ 2 and MCK TIBIAL BASEPLATE-RM/LL-SZ 7 Item No.: 180612; Lot Number: 26080317-01180617; and Lot Number: 26150217-01 Dear Customer, Stryker has initiated an urgent, voluntary, lot-specific recall for the MCK TIBIAL BASEPLATE-RM/LL-SZ 2 and MCK TIBIAL BASEPLA TE-RM/LL-SZ 7 referenced above. The intent of this letter is to inform you of the product recall that was initiated on December 01, 2017 by Stryker, and to list known hazards potentially associated with the use of the above referenced products and list the risk mitigation factors. Stryker has discovered that the packaging of certain sizes and lots of the above-referenced product may contain the incorrect product and/or label. Two reports were received with the product/label discrepancy. In one report, the labeling of the implant box outer label stated Size 2 RM/LL, and the labeling of the implant sticker (Patient label) located inside the outer box stated Size 7 RM/LL. The correct implant Size 2RM/LL was inside the box. The patient label was incorrect in this report. The second report described that a size 2 implant was in a box labeled as a size 7 implant. Potential Hazards Technical and medical assessments are currently underway to determine any potential hazards associated with the use of the product. Additional communication will be forwarded upon completion of the internal investigation on this issue. Risk Mitigation The difference in Size 2 RM/LL implant and Size 7 RM/LL implant is easily identified by the end user and would not likely be implanted as the discrepancy would be obvious. Actions Needed 1. Please inform users of this Urgent Product Recall and forward this notice to all individuals who need to be aware within your organization 2. Hospitals/Branches/Agencies: Complete and sign the enclosed Recall Notification Business Reply Form and
Quantity in Commerce 126
Distribution AL, AR, AZ, CA, CO, FL, GA, ID, IL, IN, KS, LA, MA, MD, MI, MN, NC, NE, NH, NJ, NY, OK, OR, PA, RI, SC, TX, UT, VA, WA, WY, and Hawaii Australia, Italy, Netherlands, Singapore, South Korea, United Kingdom, and Vietnam
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 Corp.
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