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Tandem 71324042

by Smith & Nephew, Inc.

Tandem 71324042 is a Class II device made by Smith & Nephew, Inc., cleared under FDA 510(k) K231448 on 19 Jul 2023 (2 earlier submissions) and listed in FDA GUDID since 30 Aug 2015 (UDI-DI 03596010494337), 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

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK231448 Date19 Jul 2023DecidedStatusActive
United StatesGUDID listing Number03596010494337 UDI-DI Date30 Aug 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • FDA 510(k) K231448 decided 19 Jul 2023 Active· +2 more in the status table
  • FDA GUDID UDI-DI 03596010494337 listed 30 Aug 2015 Listed

Recalls

3 recalls · 1 ongoing · FDA

    • Ongoing Z-0326-2025 FDA Class II initiated 15 Oct 2024

    The Bipolar assembly contains an oversized Retainer Ring.

  • 2 recalls, same reason

    • Terminated Z-0351-2017 FDA Class II initiated 29 Aug 2016
    • Terminated Z-0350-2017 FDA Class II initiated 29 Aug 2016

    Some Bipolar shells were manufactured with an out of specification retainer groove.

Timeline

7 dated events

  1. Cleared FDA 510(k) K023743
  2. Listed FDA GUDID 03596010494337
  3. Recall initiated FDA recalls Z-0351-2017
  4. Recall initiated FDA recalls Z-0350-2017
  5. Cleared FDA 510(k) K211176
  6. Cleared FDA 510(k) K231448
  7. Recall initiated FDA recalls Z-0326-2025

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Tandem
Generic name
Bipolar femoral head outer component, hemiarthroplasty
Model / Ref / Catalog
71324042
Primary DI / UDI-DI
03596010494337
510(k) Number
FDA product code
KWY
GMDN term
Bipolar femoral head outer component, hemiarthroplasty
Device class
Class II
Regulation number
888.3390
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Related devices

Category: Bipolar femoral head outer component, hemiarthroplasty

Cleared under the same submission (K023743)

and 8 more cleared under K023743

Cleared under the same submission (K211176)

and 8 more cleared under K211176

Similar devices in this category

Other devices filed under Bipolar femoral head outer component, hemiarthroplasty.

Other devices from Smith & Nephew, Inc.

See all devices from Smith & Nephew, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)