Events

Recall of Device Recall Restoris MultiCompartmental Knee (MCK) System

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
    73201
  • Event Risk Class
    Class 2
  • Event Number
    Z-1031-2016
  • Event Initiated Date
    2016-01-15
  • 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=143572
  • 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
    Prosthesis, knee patellofemorotibial, partial, semi-constrained, cemented, polymer/metal/polymer - Product Code NPJ
  • Reason
    Reports where the mylar/tyvek pouch for restoris mck baseplate in the clamshell packaging configuration exhibited damage, compromising the sterile barrier.
  • Action
    The firm, Stryker Orthopaedics, sent an "Urgent Product Recall" letter dated 1/15/2016 to all their consignees. The letter described the product, problem and actions to be taken. The consignees were instructed to inspect the device packaging as the damage to the sterile barrier may be notice prior to the procedure; do not use the device if the seal or package is breached and complete and return the attached Product Recall Acknowledgment Form within 5 days by e-mail StrykerOrtho5317@Stericycle.com or fax at: 888-480-2853. Return all affected products available at your location to: Stryker c/o Stericycle, 2670 Executive Dr., Suite A, Indianapolis, IN 46241, Attn. RA2015-047-Event 5317. If you have any questions, feel free to contact Sr. Director QA at 954-628-0502.

Device

Device Recall Restoris MultiCompartmental Knee (MCK) System
  • Model / Serial
    Catalog # 180601 - Lot #'s: 26110111, 26300512-01, 26110112-01, and 26090311-01 Catalog # 180602 - Lot #'s: LET1484311012, 26020812-01, 26220512-01, 26180711-0126120211-01, 26301011-01, 26161111-01, and 26220512-02. Catalog # 180603 - Lot #'s: LET 1388860512, 26010511-01, 26310811-01 and 26050112-01 Catalog # 180604 - Lot #'s: 26090512-01 and 26280412-01 Catalog # 180605 - Lot #'s: 26310512-01, 26270512-01, and 26250511-01 Catalog # 180606 - Lot #'s: LET1464570912, 26300412-01, 26140412-01, and 26050212-01. Catalog # 180607 - Lot #'s: 26211011-01, 26040212-01, 26330512-01, 26090611-02, 26070811-01, LET1406460512, and 26230411-01. Catalog # 180608 - Lot # 26141111-01 Catalog # 180611 - Lot #'s 26131111-01 and 26050211-01 Catalog # 180612 - Lot #'s 26190911-01, 36010112-1, 26070212-01, 26410611-01, 26020411-01, and 26060211-01 Catalog # 180613 Lot #'s 26271011-01 and 26240711-01 Catalog # 180614 - Lot #'s 36031211-1, 26180512-01, 26440611-01, and 26190612-01 Catalog # 180615 Lot # 2610012-01 Catalog # 180616 Lot #'s 26160212-01, 2634012-01, 26300811-01, 26171111-01, 26350512-01, and 26310612-01. Catalog # 180617 Lot #'s 26310412-01, 26160711-01, 26210511-02, 26061011-01, 26061011-01, and LOT1388810512. Catalog # 180618 Lot #'s: 26360512-01, 26060311-01, and 26061211-01.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution: US (nationwide) including states of: AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, LA, MI, MS, MO, NC, NH, NJ, NV, NY, OH, OK, OR, PA, RI, TN, TX, UT, VA, WA, WI, and WY ; and countries of: Italy, Scotland, Turkey, Greece, Germany, and Singapore.
  • Product Description
    Restoris Multicompartmental Knee (MCK) System || RESTORIS MCK is indicated for single or multi-compartmental knee replacement used in conjunction with RIO.
  • Manufacturer
    Mako Surgical Corporation

Manufacturer

Mako Surgical Corporation
  • Manufacturer Address
    Mako Surgical Corporation, 2555 Davie Rd Ste 110, Plantation FL 33317-7424
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA