FDAJune 23, 2016device
Stryker Orthopaedics Specialty Triathlon Tibial Alignment Handle with Secondary Lock, Non-Sterile, Used to complement or replace the standard instruments used during the implantation of hip, knee, trauma and upper extremities implants
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
It was reported that the secondary locking mechanism, and its corresponding components, disassociated from the Specialty Triathlon Tibial Alignment Handle with Secondary Lock Assembly during surgery. Upon further investigation, it was discovered that the weld, which was intended to hold the secondary locking mechanism together, did not meet the weld size specified on the engineering drawing.
What to do
FDA enforcement status: Terminated
Brands named
stryker howmedica osteonicsstrykerstryker howmedica
Recall history
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