—#210623

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.

FDA product code: KWY — Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K023743, K211176, K231448
Affected lot / code info: Batch W2401399, UDI-DI 03596010494375.

Why it was recalled

The Bipolar assembly contains an oversized Retainer Ring.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Smith & Nephew, Inc.
Address: 1450 E Brooks Rd, Memphis, Tennessee 38116-1804

Distribution

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

Timeline

Recall initiated: 2024-10-15
Posted by FDA: 2024-11-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #210623. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.