Stryker Recalls Cutting Guides Used in Triathlon Knee Implant Surgeries
May 2, 2013
DOCUMENTS
- FDA and Stryker Notices
KALAMAZOO, Mich. — The Food and Drug Administration has classified Stryker Orthopaedic’s NYSE: SYK) recent voluntary withdrawal of a bone-cutting guide used during Triathlon knee implant surgeries as “Class I,” the most serious type of recall.
The FDA issued its notice April 10, the same day Stryker issued an “Urgent Medical Device Recall” warning surgeons and other health professional of possible risks associate with its ShapeMatch Cutting Guides.
The FDA said it has received reports of 41 malfunctions and three medically reversible injuries related to use of the cutting guides, which guide the marking of bone before cutting and assist …
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