Legion E0016805-6

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

  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 ·via K121393, on the same 510(k)

  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 ·via K121393, on the same 510(k)

  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 ·via K121393, on the same 510(k)

  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 marked "via" name another device cleared under the same FDA submission as this one.

Trade Name

Legion

Generic Name

Saliva pH IVD, kit, rapid colorimetric, clinical

Model / Ref / Catalog

E0016805-6

Primary DI / UDI-DI

00885556774564

510(k) Number

K121393 ↗

FDA Product Code

HRY

GMDN Term

Saliva pH IVD, kit, rapid colorimetric, clinical

Device Class

Class II

Regulation Number

888.3530

Commercial Distribution

In Commercial Distribution

Sterilization Method

Moist Heat or Steam Sterilization

Category: Saliva pH IVD, kit, rapid colorimetric, clinical