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Tandem 71322041

by Smith & Nephew, Inc.

Tandem 71322041 is a Class II device made by Smith & Nephew, Inc., cleared under FDA 510(k) K023743 on 23 Jan 2003 and listed in FDA GUDID since 30 Aug 2015 (UDI-DI 03596010492401), 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

510(k) K023743

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 Number03596010492401 UDI-DI Date30 Aug 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Abbreviated NumberK023743 Date23 Jan 2003DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K023743 decided 23 Jan 2003 Active
  • FDA GUDID UDI-DI 03596010492401 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

5 dated events

  1. Cleared FDA 510(k) K023743
  2. Listed FDA GUDID 03596010492401
  3. Recall initiated FDA recalls Z-0351-2017
  4. Recall initiated FDA recalls Z-0350-2017
  5. 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  • Withdrawn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
71322041
Description
TANDEM BIPOLAR COBALT CHROME 41MM OUTER DIAMETER 22MM INNER DIAMETER
Primary DI / UDI-DI
03596010492401
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

Related devices

Category: Bipolar femoral head outer component, hemiarthroplasty

Cleared under the same submission (K023743)

and 8 more cleared under K023743

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)