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High RiskFDAfda-Z-0023-2025STERILITY ISSUE

Triathlon Universal TS Baseplate Size 2 - A single use sterile implantable device intended for cemented applications during primary and r...

Units Affected
16
Recall Date
September 4, 2024
Issuing Agency
Hazard
Sterility Issue

FDA Recall Notice

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0023-2025.

Anterior locking tabs on the Triathlon Universal Baseplate are out of specification which may prevent engagement of either of the two locking tabs with the locking wire of the tibial insert.

Corrective Action (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0023-2025.

Recall ongoing. Follow firm instructions.

✅ What you should do

  1. Stop using the product if you own it.
  2. Check the model number, lot code, or sell-by date against the recall notice above.
  3. Contact Howmedica Osteonics Corp. or the retailer where you bought it for a refund, replacement, or repair.
  4. For the most current official instructions, visit the FDA recall page.
  5. If you've been hurt by this product, report the incident to FDA.

Consumer Contact (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0023-2025.

Howmedica Osteonics Corp.

FDA

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If you had a reaction, found contamination, or experienced a labeling problem with this product, report it to the FDA. The agency uses consumer reports to track emerging safety signals and trigger recalls.

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Howmedica Osteonics Corp. Recall FAQ

Howmedica Osteonics Corp. is the subject of a medical implants safety report: Triathlon Universal TS Baseplate Size 2 - A single use sterile implantable device intended for cemented applications during primary and r.... The notice was published on September 4, 2024 by the U.S. Food and Drug Administration (FDA). Approximately 16 units are potentially affected.