Journey II E0016425-2

• FDA 510(k) K121393 decided 7 Aug 2012 Active
• FDA GUDID UDI-DI 00885556742112 listed 29 Mar 2019 Listed

• • Ongoing Z-0878-2020 FDA Class II ·initiated 16 Dec 2019 ·on shared 510(k) K121393

  Multiple lots of LEGION AP Femoral Cutting Blocks were manufactured with an oversize green plunger hole and therefore do not meet their design specifications.

• • Terminated Z-0200-2019 FDA Class II ·initiated 18 Sep 2018 ·on shared 510(k) K121393

  One lot of the Legion AP femoral cutting block, size 6, was manufactured with an oversized spring.

• • Terminated Z-2163-2018 FDA Class II ·initiated 4 May 2018 ·on shared 510(k) K121393

  One lot of GENESIS II 13 mm tibial punches are 2 mm smaller than specification.

• • Terminated Z-1902-2018 FDA Class II ·initiated 9 Apr 2018 ·on shared 510(k) K121393

  A single lot of GENESIS II FEMORAL FIVE DEGREE VALGUS BUSHING due to a laser mark labeling error. The left valgus bushing was incorrectly laser marked as right and vice versa.

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

1. 7 Aug 2012 Cleared FDA 510(k) K121393
2. 9 Apr 2018 Recall initiated FDA recalls Z-1902-2018
3. 4 May 2018 Recall initiated FDA recalls Z-2163-2018
4. 18 Sep 2018 Recall initiated FDA recalls Z-0200-2019
5. 29 Mar 2019 Listed FDA GUDID 00885556742112
6. 16 Dec 2019 Recall initiated FDA recalls Z-0878-2020

Trade name

Journey II

Generic name

Bone approximation clamp

Model / Ref / Catalog

E0016425-2

Primary DI / UDI-DI

00885556742112

510(k) Number

K121393 ↗

FDA product code

HRY

GMDN term

Bone approximation clamp

Device class

Class II

Regulation number

888.3530

GUDID distribution status

In Commercial Distribution

Sterilisation method

Moist Heat or Steam Sterilization

Category: Bone approximation clamp

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