Dynasty 205478

• FDA 510(k) K121064 decided 6 Jun 2012 Active
• FDA GUDID UDI-DI 00848486022006 listed 24 Sep 2016 Listed

• • Terminated Z-1735-2022 FDA Class II ·initiated 8 Aug 2022

  Certain units have the potential to exhibit infant failures whereby units either arrive non-functional, have the potential to become non-functional, or flash an error light while in use.

• • Terminated Z-2925-2018 FDA Class II ·initiated 24 Jul 2018

  Specific lots of the Vizadisc Knee Procedure Tracking Kit and Vizadisc Hip Procedure Tracking Kit have the potential to be damaged on the Vizadisc reflective material causing an inability to be detected by the camera.

• • Terminated Z-3131-2017 FDA Class II ·initiated 7 Aug 2017

  Software discrepancy of not showing all the EE constants, when the screen is filled.

• • Terminated Z-1411-2017 FDA Class II ·initiated 22 Dec 2016

  Five (5) AFMEA Risk Control Measures are missing from the MAKO RIO THA Application User Guides

• • Terminated Z-1193-2017 FDA Class II ·initiated 29 Sep 2016

  Failure of the Offset Cup Reamer Handle not engaging its mating components.

• • Terminated Z-1583-2016 FDA Class II ·initiated 23 Feb 2016

  Potential disassociation of the orientation pin.

• • Terminated Z-1588-2016 FDA Class II ·initiated 25 Nov 2015

  Stryker Orthpaedics became aware that there is the potential for the 210540 MAKOplasty Hip Array Kit Laminate 150230 to list two part numbers for the RIO Base Array, which is item #5 on the product table.

• • Terminated Z-0224-2016 FDA Class II ·initiated 16 Jul 2015

  The locking pin on the RIO Base Array is damaged during assembly onto the RIO Base Array Connector.

• 3 recalls, same reason

  • Terminated Z-0829-2015 FDA Class II ·initiated 7 Oct 2014
  • Terminated Z-0830-2015 FDA Class II ·initiated 7 Oct 2014
  • Terminated Z-0828-2015 FDA Class II ·initiated 7 Oct 2014

  MAKO has identified the potential that the shell impactors may be damaged intraoperatively.

• • Terminated Z-1508-2016 FDA Class II ·initiated 30 Apr 2014

  Revision of the field manual

1. 7 Oct 2014 Recall initiated FDA recalls Z-0828-2015
2. 16 Jul 2015 Recall initiated FDA recalls Z-0224-2016
3. 25 Nov 2015 Recall initiated FDA recalls Z-1588-2016
4. 23 Feb 2016 Recall initiated FDA recalls Z-1583-2016
5. 24 Sep 2016 Listed FDA GUDID 00848486022006
6. 29 Sep 2016 Recall initiated FDA recalls Z-1193-2017
7. 22 Dec 2016 Recall initiated FDA recalls Z-1411-2017
8. 7 Aug 2017 Recall initiated FDA recalls Z-3131-2017
9. 24 Jul 2018 Recall initiated FDA recalls Z-2925-2018
10. 8 Aug 2022 Recall initiated FDA recalls Z-1735-2022

4 earlier events are in the sections above.

Trade name

Dynasty

Generic name

Orthopaedic implant impactor, reusable

Model / Ref / Catalog

205478

Primary DI / UDI-DI

00848486022006

FDA product code

OLO

GMDN term

Orthopaedic implant impactor, reusable

Device class

Class II

Regulation number

882.4560

GUDID distribution status

In Commercial Distribution

Sterilisation method

Moist Heat or Steam Sterilization

Category: Orthopaedic implant impactor, reusable

Other devices filed under Orthopaedic implant impactor, reusable.

• KHEIRON 01PC2010 by S.M.A.I.O
• APEX Knee System KS-61108 by OMNIlife science, Inc.
• impactor for cup insert 02820007 by implantcast GmbH
• ACS® 42102214 by implantcast GmbH
• Comprehensive® SRS Instrument 405191 by Biomet Orthopedics, Inc.
• Unity Total Knee System 1231050 by CORIN LTD
• APEX Knee System X785-01 by OMNIlife science, Inc.
• VerSys® 7896-52 00-7896-052-00 by Zimmer, Inc.
• MobiliT Cup MDM058 MDM059 by CORIN LTD
• GAMMA 1320-0175 by Stryker GmbH

• Mako

  Class I

  CE/MDR

• TD-03 - MAKO - Class IIa - Irrigation Clip - Consumables - Plastic

  Class IIa

  CE/MDR

• Mako 180734-5-E

  Class II

  GUDID on market

• Mako 700000625059 Open recall

  Class II

  CE/MDR FDA 510(k) ×2 Active Cleared 15 Apr 2022 +1authorizations

See all devices from MAKO Surgical Corp. →