FDASeptember 21, 2015device
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 th...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Stryker Orthopaedics has received two customer complaints regarding Duracon Tibial Wedge implants puncturing the packaging's Tyvek lid(s).
What to do
FDA enforcement status: Terminated
Brands named
stryker howmedica osteonicsstrykerstryker howmedica
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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