FDA-Device2016-08-17Class II
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
Stryker Howmedica Osteonics Corp.
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.
Sold states
Nationwide Distribution to FL, IN, LA, NC, PA, TN and UT
Affected count
47 units
Manufactured in
325 Corporate Dr, Mahwah, NJ, United States
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2390-2016Don't want to check this manually?
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