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Recall Observatory FDA recall evidence

Device product

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

Z-2390-2016

June 23, 2016

Class II

Product summary

Firm
Stryker Howmedica Osteonics Corp.
Event
Event 74619
Status
Terminated
Classification
Class II
Quantity
47 units
Official record key
device-enforcement:Z-2390-2016

Official wording

Reason: 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.

Code information: Catalog No: I-K3254TA00 Lot Nos: F6E13243, F6L13864, F6M14078, F6S14667, F6S14831, F6W15444, F6W15406, F7C15943, F7H16099 and F7L16994

Distribution pattern: Nationwide Distribution to FL, IN, LA, NC, PA, TN and UT

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.