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Recall Observatory FDA recall evidence

Device product

Stryker Orthopaedics Duracon Flat Tibial Wedge Cemented use only Sterile. Tibial Wedge is a component of Total Stabilizer Knee which consists of femoral component, tibial insert, modular offset adaptor, femoral/tibial stem extenders and tibial wedges. Tibial wedges are intended to be used with the Universal tibial baseplate to augment bone loss on the surface of the tibia.

Z-0362-2016

September 21, 2015

Class II

Product summary

Firm
Stryker Howmedica Osteonics Corp.
Event
Event 72498
Status
Terminated
Classification
Class II
Quantity
2,577 units
Official record key
device-enforcement:Z-0362-2016

Official wording

Reason: Stryker Orthopaedics has received two customer complaints regarding Duracon Tibial Wedge implants puncturing the packaging's Tyvek lid(s).

Code information: Multiple Lot Numbers. Catalog Numbers: 6630-6-105, 6630-6-110, 6630-6-125, 6630-6-130, 6630-6-150, 6630-6-155, 6630-6-170, 6630-6-175, 6630-6-205, 6630-6-210, 6630-6-225, 6630-6-230, 6630-6-250, 6630-6-255, 6630-6-270, 6630-6-275, 6630-6-305, 6630-6-310, 6630-6-325, 6630-6-330, 6630-6-350, 6630-6-355, 6630-6-370, 6630-6-375, 6630-6-405, 6630-6-410, 6630-6-425, 6630-6-430, 6630-6-450, 6630-6-455, 6630-6-470 and 6630-6-475.

Distribution pattern: Distributed US (nationwide) and the countries of Australia, Canada, Germany, Hong Kong, Italy, Japan, Malaysia, New Zealand, Netherlands, Poland, Romania, Spain, Sweden and Switzerland.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Stryker Orthopaedics has received two customer complaints regarding Duracon Tibial Wedge implants puncturing the packaging's Tyvek lid(s).