Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00885556867099 UDI-DI	Date6 Dec 2021Listed	StatusListed GUDID: in commercial distribution

Recalls

4 recalls · 1 ongoing · FDA

- 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 jurisdiction

United States — GUDID listing Listed

GUDID

Trade Name: No Brand
Generic Name: Orthopaedic prosthesis implantation positioning instrument, reusable
Model / Ref / Catalog: XK000696-5
Description: EXPRESS 4-IN-1 AP CUTTING BLOCK SIZE 0

Primary DI / UDI-DI: 00885556867099
510(k) Number: K121393
FDA Product Code: JWH
GMDN Term: Orthopaedic prosthesis implantation positioning instrument, reusable

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