FDA Medical Device Recalls (openFDA)
Smith & Nephew, Inc.: 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.
- Recall number
- Z-0326-2025
- 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.
- Status
- Open, Classified
- Initiated
- 2024-10-15
- Posted
- 2024-11-07
- Terminated
- not on file
- Reason
- The Bipolar assembly contains an oversized Retainer Ring.
- 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
- 21 devices
- Distribution
- International distribution to the countries of Australia, Belgium, Canada, Germany, Italy, Panama, Poland, Spain, and Turkey.
- Lot, serial or model codes
- Batch W2401399, UDI-DI 03596010494375.
- 510(k) numbers
- ["K211176","K231448","K023743"]
- PMA numbers
- not on file
- Product code
- KWY
- Firm FEI
- 1020279
- Firm city
- Memphis
- Firm state
- TN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28