Knee Replacement Implant Recalled for Out-of-Spec Locking Tabs
The FDA is recalling the Triathlon Universal TS Baseplate Size 2 knee implant due to defective locking tabs that may not properly engage with the tibial insert, potentially causing implant failure.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II surgical implant with a manufacturing defect affecting a critical functional component (locking mechanism) that could result in implant failure. No injuries or illnesses have been reported. The defect presents significant risk of harm if the implant fails to engage properly during surgery.
Plain-English summary
The FDA is recalling the Triathlon Universal TS Baseplate Size 2, a surgical implant used during knee replacement procedures (Total Knee Arthroplasty). The recall affects 16 units with lot numbers LZX4LB and OLH7VA distributed nationwide to facilities in Arizona, Florida, North Carolina, Ohio, Pennsylvania, Tennessee, and Wisconsin.
The anterior locking tabs on the baseplate are manufactured out of specification, which may prevent proper engagement with the locking wire of the tibial insert. This defect could result in improper implant fixation and potential mechanical failure during or after surgery.
Healthcare facilities that received these devices should immediately check their inventories and quarantine any affected units. These devices should not be implanted. Facilities must complete and return the Urgent Medical Device Recall Business Reply Form within 5 days and contact Stryker or their local sales office for replacement devices. Affected units should be returned to Stryker Orthopaedics in Mahwah, New Jersey using reference number PFA 3554908.
The recalled product
- Product
- Triathlon Universal TS Baseplate Size 2 - A single use sterile implantable device intended for cemented applications during primary and revision Total Knee Arthroplasty (TKA) when the Triathlon Knee System is selected for use. Catalog Number: 5521-B-200
- Manufacturer
- Howmedica Osteonics Corp.
- Hazard
- surgical-implant-defect
- locking-mechanism-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI-DI: 07613327026306 Lot numbers: LZX4LB
- OLH7VA
Distribution
Distributed nationwide across the United States.
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