External Distraction System 01-5918

• FDA 510(k) K831005 decided 18 May 1983 Active
• FDA GUDID UDI-DI 00841036011314 listed 25 Nov 2015 Listed

• 13 recalls, same reason

  • Terminated Z-2231-2018 FDA Class II ·initiated 16 May 2018
  • Terminated Z-2241-2018 FDA Class II ·initiated 16 May 2018
  • Terminated Z-2240-2018 FDA Class II ·initiated 16 May 2018
  • Terminated Z-2242-2018 FDA Class II ·initiated 16 May 2018
  • Terminated Z-2235-2018 FDA Class II ·initiated 16 May 2018
  • Terminated Z-2234-2018 FDA Class II ·initiated 16 May 2018
  • Terminated Z-2233-2018 FDA Class II ·initiated 16 May 2018
  • Terminated Z-2236-2018 FDA Class II ·initiated 16 May 2018
  • Terminated Z-2239-2018 FDA Class II ·initiated 16 May 2018
  • Terminated Z-2237-2018 FDA Class II ·initiated 16 May 2018
  • Terminated Z-2238-2018 FDA Class II ·initiated 16 May 2018
  • Terminated Z-2230-2018 FDA Class II ·initiated 16 May 2018
  • Terminated Z-2232-2018 FDA Class II ·initiated 16 May 2018

  The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier failure. Guide wires packaged in the affected packaging configuration have the potential for sterile barrier breach, leading to possible risk for infection.

• • Terminated Z-0087-2017 FDA Class II ·initiated 2 Aug 2016

  The G-PIN 2.8BL 3.2PL 60 CM 2PK is intended to contain one (1) 467265-01 Ball Tip Guide Pin and one (1) 467255-02 Plain Tip Guide Pin. The G-PIN 2.8BL 3.2PL 60 CM 2PK may have been packaged incorrectly either with two (2) 467265-01 Ball Tip Guide Pins and zero (0) 467255-02 Plain Tip Guide Pins or with zero (0) 467265-01 Ball Tip Guide Pins and two (2) 467255-02 Plain Tip Guide Pins. If the G-PIN 2.8BL 3.2PL 60 CM 2PK contains the incorrect combination of Plain Tip Guide Pins and Ball Tip Guide Pins, the surgeon would either have to implant the nail without the Plain Tip Guide Pin as a guide, ream with a Plain Tip Guide Pin, or choose to not ream the humeral canal. The risk associated with not having the correct combination can include a delay in surgery of less than 30 minutes, the reamer tip remaining in the distal humeral canal, or an iatrogenic fracture.

• • Terminated Z-1822-2016 FDA Class II ·initiated 1 Apr 2016

  Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the product becomes non-sterile and is used or implanted, it may lead to an infection.

1. 16 May 2018 Recall initiated FDA recalls Z-2242-2018
2. 16 May 2018 Recall initiated FDA recalls Z-2235-2018
3. 16 May 2018 Recall initiated FDA recalls Z-2234-2018
4. 16 May 2018 Recall initiated FDA recalls Z-2233-2018
5. 16 May 2018 Recall initiated FDA recalls Z-2236-2018
6. 16 May 2018 Recall initiated FDA recalls Z-2239-2018
7. 16 May 2018 Recall initiated FDA recalls Z-2237-2018
8. 16 May 2018 Recall initiated FDA recalls Z-2238-2018
9. 16 May 2018 Recall initiated FDA recalls Z-2230-2018
10. 16 May 2018 Recall initiated FDA recalls Z-2232-2018

7 earlier events are in the sections above.

Trade name

External Distraction System

Generic name

Orthopaedic bone wire

Model / Ref / Catalog

01-5918

Primary DI / UDI-DI

00841036011314

510(k) Number

K831005 ↗

FDA product code

HTY

GMDN term

Orthopaedic bone wire

Device class

Class II

Regulation number

888.3040

GUDID distribution status

In Commercial Distribution

Sterilisation method

Moist Heat or Steam Sterilization

Category: Orthopaedic bone wire

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