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Legion E0015357-2

by Smith & Nephew, Inc.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

3 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00885556676332 UDI-DI Date30 Jan 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK121393 Date7 Aug 2012DecidedStatusActive

Official records

Recalls

7 recalls · 3 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-0158-2024 FDA Class II initiated 27 Sep 2023
    • Ongoing Z-0157-2024 FDA Class II initiated 27 Sep 2023

    The JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM. And also, a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM.

    • 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-1099-2022 FDA Class II initiated 19 Apr 2022

    It was reported that a JOURNEY II BCS Femoral OXIN LT SZ5 was in a box labelled as a LEGION NARROW PS OXIN SZ 6N RT.

    • 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.

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  • Withdrawn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
Surgical implant template, reusable
Model / Ref / Catalog
E0015357-2
Primary DI / UDI-DI
00885556676332
510(k) Number
FDA product code
JWH
GMDN term
Surgical implant template, reusable
Device class
Class II
Regulation number
888.3560
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Surgical implant template, reusable

Cleared under the same submission (K111711)

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Cleared under the same submission (K121393)

Show all (12)

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)

  • Supplied sterile: No
  • Single use: No
  • Implantable: No
  • Contains latex: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No
  • Expiration date: No
  • Manufacturing date: No