FDAJuly 1, 2015device
8.5mm Reamer Head for Flexible Intramedullary Nailing System; An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The possibility exists for intraoperative reamer head breakages which could also allow for un-retrieved fragments of non-implant grade material: additional lot numbers identified. No new adverse events reported.
What to do
FDA enforcement status: Terminated
Brands named
synthes usa productssynthessynthes usa
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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