K-Wire 14-450385

• EUDAMED Basic UDI-DI B-00887868522468 registered 24 Oct 2026 Active
• FDA 510(k) K140891 decided 3 Jun 2014 Active· +1 more in the status table
• FDA GUDID UDI-DI 00887868522468 listed 10 Mar 2021 Listed

• 2 recalls, same reason

  • Terminated Z-0618-2021 FDA Class II ·initiated 25 Nov 2020
  • Terminated Z-0617-2021 FDA Class II ·initiated 25 Nov 2020

  Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.

• 2 recalls, same reason

  • Terminated Z-2303-2020 FDA Class II ·initiated 14 May 2020
  • Terminated Z-2304-2020 FDA Class II ·initiated 14 May 2020

  Distributed to the field without having completed design history files or design transfer activities

• 13 recalls, same reason

  • Terminated Z-2233-2018 FDA Class II ·initiated 16 May 2018 ·on shared 510(k) K831005
  • Terminated Z-2236-2018 FDA Class II ·initiated 16 May 2018 ·on shared 510(k) K831005
  • Terminated Z-2239-2018 FDA Class II ·initiated 16 May 2018 ·on shared 510(k) K831005
  • Terminated Z-2237-2018 FDA Class II ·initiated 16 May 2018 ·on shared 510(k) K831005
  • Terminated Z-2230-2018 FDA Class II ·initiated 16 May 2018 ·on shared 510(k) K831005
  • Terminated Z-2232-2018 FDA Class II ·initiated 16 May 2018 ·on shared 510(k) K831005
  • Terminated Z-2235-2018 FDA Class II ·initiated 16 May 2018 ·on shared 510(k) K831005
  • Terminated Z-2234-2018 FDA Class II ·initiated 16 May 2018 ·on shared 510(k) K831005
  • Terminated Z-2231-2018 FDA Class II ·initiated 16 May 2018 ·on shared 510(k) K831005
  • Terminated Z-2238-2018 FDA Class II ·initiated 16 May 2018 ·on shared 510(k) K831005
  • Terminated Z-2241-2018 FDA Class II ·initiated 16 May 2018 ·on shared 510(k) K831005
  • Terminated Z-2240-2018 FDA Class II ·initiated 16 May 2018 ·on shared 510(k) K831005
  • Terminated Z-2242-2018 FDA Class II ·initiated 16 May 2018 ·on shared 510(k) K831005

  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-1064-2018 FDA Class II ·initiated 7 Dec 2017

  One lot of 3.5mm x 24mm Cortical Locking screws is labeled as 6.5mm x 125mm x 16mm Cannulated screws.

• • Terminated Z-0087-2017 FDA Class II ·initiated 2 Aug 2016 ·on shared 510(k) K831005

  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 ·on shared 510(k) K831005

  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.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

1. 16 May 2018 Recall initiated FDA recalls Z-2238-2018
2. 16 May 2018 Recall initiated FDA recalls Z-2241-2018
3. 16 May 2018 Recall initiated FDA recalls Z-2240-2018
4. 16 May 2018 Recall initiated FDA recalls Z-2242-2018
5. 14 May 2020 Recall initiated FDA recalls Z-2303-2020
6. 14 May 2020 Recall initiated FDA recalls Z-2304-2020
7. 25 Nov 2020 Recall initiated FDA recalls Z-0618-2021
8. 25 Nov 2020 Recall initiated FDA recalls Z-0617-2021
9. 10 Mar 2021 Listed FDA GUDID 00887868522468
10. 24 Oct 2026 Registered EUDAMED B-00887868522468

14 earlier events are in the sections above.

Trade name

K-Wire

Generic name

Orthopaedic bone wire

Model / Ref / Catalog

14-450385

Primary DI / UDI-DI

00887868522468

Basic UDI-DI

B-00887868522468

510(k) Number

K140891 ↗

K831005 ↗

FDA product code

HWC

EMDN code

P091399 Orthopaedic implant instruments, single-use - other

GMDN term

Orthopaedic bone wire

Device class

Class IIa EUDAMED

Class II GUDID

Regulation number

888.3040

EU registration type

Legacy device (under a directive)

EU market of registration

Netherlands

GUDID distribution status

In Commercial Distribution

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Category: Orthopaedic bone wire

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