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

FDA device recall Z-0326-2025 · posted 2024-11-07 · Open, Classified

Recall details

Recalling firm

Smith & Nephew, Inc.

Reason for recall

The Bipolar assembly contains an oversized Retainer Ring.

Action taken

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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

KWY

Quantity affected

21 devices

Distribution

International distribution to the countries of Australia, Belgium, Canada, Germany, Italy, Panama, Poland, Spain, and Turkey.

Date initiated

2024-10-15

Date posted

2024-11-07

Location

Memphis, TN

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