Howmedica Osteonics Corp.: Triathlon Universal TS Baseplate Size 2 - A single use sterile implantable device intended for cemented applications during primary and revision Total Knee Arthroplasty (TKA

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: US Nationwide distribution in the states of AZ, FL, NC, OH, PA, TN, WI. Stryker issued Urgent Medical Device Recall (UMDR) PFA 3554908 by third party Sedgwick on September 04, 2024, via UPS 2-day air. Letter states reason for recall, health risk and action to take: 1. Please inform users of this Urgent Medical Device Recall and forward this notice to all individuals who need to be made aware or or Quantity: 16 units Lot/code info: UDI-DI: 07613327026306 Lot numbers: LZX4LB, OLH7VA

UPC codes

07613327026306

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.