FDAFDA · Food and drugs·Recall number Z-2360-2015
Triathlon PS X3 Tibial Insert; No. 3 Triathlon TS Plus Tibial Insert X3 Poly 19 mm Product Usage: The Triathlon PS X3 (posterior stabilized), cat no 5532-G-xxx and X3 TS (total stabilizing) Plus, cat. no. 5537-G-XXX, Tibial Inserts are used in TKA surgeries. During surgery, the tibial insert is locked into the tibial baseplate where it serves as the bearing component for the articulating surface of a corresponding Triathlon femoral component.
Published August 19, 2015 · Recall initiated: May 29, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Stryker Orthopaedics received a report that 5537-G-319 No 3. Triathlon TS Plus Tibial Insert X3 Poly 19 mm i insert was in a package labeled as a 5532-G-511 Triathlon PS Stibialism Insert.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Stryker Howmedica Osteonics Corp.
- Distributor
- Worldwide Distribution - US Nationwide
- Lot
- Catalog Number 5532-G-511 Lot LD8D7Y Catalog Number 5537-G-319 Lot TT6JT2
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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