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Recall Observatory FDA recall evidence

Device product

Stryker Orthopaedics Tapers LFIT V40 Vitallium femoral heads. hip prosthesis component.

Z-0261-2016

September 08, 2015

Class II

Product summary

Firm
Stryker Howmedica Osteonics Corp.
Event
Event 72297
Status
Terminated
Classification
Class II
Quantity
201
Official record key
device-enforcement:Z-0261-2016

Official wording

Reason: Complaints that the femoral head could not be assembled with its corresponding V40 stem trunnion at the time of surgery.

Code information: Catalog Numbers 6260-5-028; 6260-5-032; 6260-5-132; 6260-5-232, 232; 6260-5-328; 6260-5-332; 6260-5-428; 6260-5-432; 6260-9-0928; 6260-9-032, 6260-9-132, 6260-9-232, 6260-9-328, 6260-9-332, 6260-9-428, 6280-0-128, 6280-0-228, 6280-0-232, 6280-0-332 exp- dates july 2019 to august 2019

Distribution pattern: Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Complaints that the femoral head could not be assembled with its corresponding V40 stem trunnion at the time of surgery.