Events

Recall of Device Recall RESTORIS MCK TIBIAL BASEPLATE

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Mako Surgical Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    79585
  • Event Risk Class
    Class 2
  • Event Number
    Z-1644-2018
  • Event Initiated Date
    2017-12-01
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162697
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Orthopedic stereotaxic instrument - Product Code OLO
  • Reason
    Incorrect product and/or label. sizing is labeled incorrectly.
  • 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

Device

Device Recall RESTORIS MCK TIBIAL BASEPLATE
  • Model / Serial
    Size 2 Item # 180612 Lot # 26080317-01 and  Size 7 Item # 180617 Lot # 26150217-01.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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
  • Product Description
    RESTORIS MCK TIBIAL BASEPLATE-RM/LL used in unicompartmental knee arthroplasty and knee replacements.
  • Manufacturer
    Mako Surgical Corporation

Manufacturer

Mako Surgical Corporation
  • Manufacturer Address
    Mako Surgical Corporation, 2555 Davie Rd Ste 110, Davie FL 33317-7424
  • Source
    USFDA