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TANDEM recallZ-0326-2025 · Smith & Nephew, Inc. · initiated Oct 15, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Smith & Nephew, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

The Bipolar assembly contains an oversized Retainer Ring.

FDA root cause category: Under Investigation by firm

What the company is doing

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.

Recall details

Recall number
Z-0326-2025
Status
Open, Classified
Initiated by the company
Oct 15, 2024
Posted by the FDA
Nov 7, 2024
Recalling firm
Smith & Nephew, Inc.
Quantity
21 devices
Product code
KWY
FDA submissions
K211176, K231448, K023743
Distribution
International distribution to the countries of Australia, Belgium, Canada, Germany, Italy, Panama, Poland, Spain, and Turkey.

Product description

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.

Code information (models, lots, serial numbers)

Batch W2401399, UDI-DI 03596010494375.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

441 devices cleared under K211176, K231448, K023743 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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