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Jii E0016957-4

by Smith & Nephew, Inc.

Jii E0016957-4 is a Class II device made by Smith & Nephew, Inc., cleared under FDA 510(k) K111711 on 16 Sep 2011 and listed in FDA GUDID since 4 May 2020 (UDI-DI 00885556783214), active as of 23 Oct 2026. 3 FDA recalls are linked to it.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 ongoing

This device is named in the recall

Documents

510(k) K111711

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 Number00885556783214 UDI-DI Date4 May 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Abbreviated NumberK111711 Date16 Sep 2011DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K111711 decided 16 Sep 2011 Active
  • FDA GUDID UDI-DI 00885556783214 listed 4 May 2020 Listed

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.

Timeline

5 dated events

  1. Cleared FDA 510(k) K111711
  2. Listed FDA GUDID 00885556783214
  3. Recall initiated FDA recalls Z-1099-2022
  4. Recall initiated FDA recalls Z-0158-2024
  5. Recall initiated FDA recalls Z-0157-2024

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Jii
Generic name
Osteotomy guide, reusable
Model / Ref / Catalog
E0016957-4
Primary DI / UDI-DI
00885556783214
510(k) Number
FDA product code
JWH
GMDN term
Osteotomy guide, 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: Osteotomy guide, reusable

Cleared under the same submission (K111711)

and 8 more cleared under K111711

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)