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Legion E0016532-1

by Smith & Nephew, Inc.

Legion E0016532-1 is a Class II device made by Smith & Nephew, Inc., cleared under FDA 510(k) K121393 on 7 Aug 2012 and listed in FDA GUDID since 22 May 2019 (UDI-DI 00885556754382), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

Recall on shared 510(k) K121393; other models may be affected

Documents

510(k) K121393

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00885556754382 UDI-DI Date22 May 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK121393 Date7 Aug 2012DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K121393 decided 7 Aug 2012 Active
  • FDA GUDID UDI-DI 00885556754382 listed 22 May 2019 Listed

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.

Timeline

6 dated events

  1. Cleared FDA 510(k) K121393
  2. Recall initiated FDA recalls Z-1902-2018
  3. Recall initiated FDA recalls Z-2163-2018
  4. Recall initiated FDA recalls Z-0200-2019
  5. Listed FDA GUDID 00885556754382
  6. Recall initiated FDA recalls Z-0878-2020

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Legion
Generic name
Osteotomy guide, reusable
Model / Ref / Catalog
E0016532-1
Primary DI / UDI-DI
00885556754382
510(k) Number
FDA product code
HRY
GMDN term
Osteotomy guide, reusable
Device class
Class II
Regulation number
888.3530
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Osteotomy guide, reusable

Cleared under the same submission (K121393)

and 8 more cleared under K121393

Other devices from Smith & Nephew, Inc.

See all devices from Smith & Nephew, Inc. →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
Other properties (12, all answered No)