Z-0326-2025Class II

Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM O.D., REF 71324046...

Name: Z-0326-2025 Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM O.D., REF 71324046...
Creator: Smith & Nephew, Inc.
Published: 2024-10-15
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2024-10-15 / Open, Classified

FDA source

Smith & Nephew, Inc. began a recall of Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM O.D., REF 71324046, sterile, femoral head bipolar component of the... on 2024-10-15. FDA classified it as Class II and gives the reason as "The Bipolar assembly contains an oversized Retainer Ring". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0326-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-10-15
Posted: 2024-11-07
Recalling firm: Smith & Nephew, Inc.
Product: Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM O.D., REF 71324046, sterile, femoral head bipolar component of the Tandem Bipolar Hip System.
Product code: KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Reason for recall: The Bipolar assembly contains an oversized Retainer Ring.
FDA root cause: Under Investigation by firm
Action: The recalling firm issued letters on and dated 15-Oct-2024 via email informing the consignee of the issue, patient impact, risks to health, and actions to be taken by the user. The actions include: 1. Ensure that the contents of this Field Safety Notice are read and understood by those within your organization who may use the Tandem Bipolar 46OD 28ID. 2. Locate and quarantine affected devices immediately. If you have further distributed the product to other organizations, please inform them at once of this Field Action and provide them with a copy of this letter. 3. Please complete the Customer Response form and email or fax it to your national Smith+Nephew agency/distributor. 4. Return quarantined product to your national Smith+Nephew agency/distributor. 5. Please maintain awareness of this notice and resulting action for an appropriate period to ensure the effectiveness of the corrective action. A Customer Response Form was enclosed for completion and return and a Physician Communication was enclosed to inform physicians of much of the same information as was contained in the Field Safety Notice regarding the issue and risks to health.
Quantity in commerce: 21 devices
Distribution: International distribution to the countries of Australia, Belgium, Canada, Germany, Italy, Panama, Poland, Spain, and Turkey.
Product codes and lots: Batch W2401399, UDI-DI 03596010494375.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0326-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0326-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-11-13	2024-11-07

Product code KWY

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)