Advanced Limb Reconstruction System 1

• FDA 510(k) K955848 decided 20 Mar 1996 Active
• FDA GUDID UDI-DI 18053504366072 listed 19 Apr 2019 Listed

• 21 recalls, same reason

  • Terminated Z-0390-2020 FDA Class II ·initiated 27 Sep 2018
  • Terminated Z-0375-2020 FDA Class II ·initiated 27 Sep 2018
  • Terminated Z-0382-2020 FDA Class II ·initiated 27 Sep 2018
  • Terminated Z-0383-2020 FDA Class II ·initiated 27 Sep 2018
  • Terminated Z-0374-2020 FDA Class II ·initiated 27 Sep 2018
  • Terminated Z-0373-2020 FDA Class II ·initiated 27 Sep 2018
  • Terminated Z-0393-2020 FDA Class II ·initiated 27 Sep 2018
  • Terminated Z-0379-2020 FDA Class II ·initiated 27 Sep 2018
  • Terminated Z-0391-2020 FDA Class II ·initiated 27 Sep 2018
  • Terminated Z-0384-2020 FDA Class II ·initiated 27 Sep 2018
  • Terminated Z-0381-2020 FDA Class II ·initiated 27 Sep 2018
  • Terminated Z-0392-2020 FDA Class II ·initiated 27 Sep 2018
  • Terminated Z-0377-2020 FDA Class II ·initiated 27 Sep 2018
  • Terminated Z-0378-2020 FDA Class II ·initiated 27 Sep 2018
  • Terminated Z-0387-2020 FDA Class II ·initiated 27 Sep 2018
  • Terminated Z-0386-2020 FDA Class II ·initiated 27 Sep 2018
  • Terminated Z-0385-2020 FDA Class II ·initiated 27 Sep 2018
  • Terminated Z-0376-2020 FDA Class II ·initiated 27 Sep 2018
  • Terminated Z-0380-2020 FDA Class II ·initiated 27 Sep 2018
  • Terminated Z-0388-2020 FDA Class II ·initiated 27 Sep 2018
  • Terminated Z-0389-2020 FDA Class II ·initiated 27 Sep 2018

  As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance.

• 2 recalls, same reason

  • Terminated Z-1435-2010 FDA Unclassified (pre-2012) ·initiated 22 Feb 2010
  • Terminated Z-1434-2010 FDA Unclassified (pre-2012) ·initiated 22 Feb 2010

  During standard quality controls, firm identified a potential for breakage of the XCaliber clamp when locking the cam.

1. 27 Sep 2018 Recall initiated FDA recalls Z-0377-2020
2. 27 Sep 2018 Recall initiated FDA recalls Z-0378-2020
3. 27 Sep 2018 Recall initiated FDA recalls Z-0387-2020
4. 27 Sep 2018 Recall initiated FDA recalls Z-0386-2020
5. 27 Sep 2018 Recall initiated FDA recalls Z-0385-2020
6. 27 Sep 2018 Recall initiated FDA recalls Z-0376-2020
7. 27 Sep 2018 Recall initiated FDA recalls Z-0380-2020
8. 27 Sep 2018 Recall initiated FDA recalls Z-0388-2020
9. 27 Sep 2018 Recall initiated FDA recalls Z-0389-2020
10. 19 Apr 2019 Listed FDA GUDID 18053504366072

15 earlier events are in the sections above.

Trade name

Advanced Limb Reconstruction System

Generic name

External orthopaedic fixation system, reusable

Model / Ref / Catalog

1, 530556

Primary DI / UDI-DI

18053504366072

510(k) Number

K955848 ↗

FDA product code

JDW

GMDN term

External orthopaedic fixation system, reusable

Device class

Class II

Regulation number

888.3040

GUDID distribution status

In Commercial Distribution

Sterilisation method

Moist Heat or Steam Sterilization

Category: External orthopaedic fixation system, reusable

Other devices filed under External orthopaedic fixation system, reusable.

• 540-20038 by TDM Co., Ltd.
• TransFx™ 4452-92-11 00-4452-092-11 by Zimmer, Inc.
• HOFFMANN 4922-1-002 by Stryker Corp.
• ST.A.R. 90 F4 Flexion and extension device - elbow F4-0230 by Citieffe
• 540-20042 by TDM Co., Ltd.
• Angled Clamp 909993 by Biomet Orthopedics, Inc.
• HOFFMANN 4921-2-160 by Stryker Corp.

• Surgical Instruments 1

  Class II

  CE/MDR FDA 510(k) K955848 Active Cleared 20 Mar 1996 +1authorizations

• Wrist Fixation Systems 1

  Class II

  CE/MDR FDA 510(k) K955848 Active Cleared 20 Mar 1996 +1authorizations

• Orthofix Modulsystem 1

  Class II

  CE/MDR FDA 510(k) K955848 Active Cleared 20 Mar 1996 +1authorizations

• Orthofix Chimaera Hip Fracture System - Trochanteric Nailing System 1

  Class II

  CE/MDD FDA 510(k) K173458 Active Cleared 7 Dec 2017 +1authorizations

See all devices from Orthofix, Inc. →