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Legion E0016685-2

by Smith & Nephew, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

2 ongoing

This device is named in the recall

Documents

None

No authorization 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 Number00885556765401 UDI-DI Date4 Sep 2019ListedStatusListed GUDID: in commercial distribution

Recalls

3 recalls · 2 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.

    • 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.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Legion
Generic Name
Surgical implant template, reusable
Model / Ref / Catalog
E0016685-2
Primary DI / UDI-DI
00885556765401
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
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Category: Surgical implant template, reusable

Cleared under the same submission (K111711)

Show all (12)

Other devices from Smith & Nephew, Inc.

See all devices from Smith & Nephew, Inc. →

Properties

  • Prescription Use
  • Lot / Batch Number

Other properties (12)

  • 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