FDASeptember 27, 2022device
SPEED 15X12X12mm Continuous Compression Implant, Product No. SE-1512
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The subject products are being recalled because they contain the incorrect size drill guide and will not prepare the bone correctly for the size of the implant included in the sterile kit. If the incorrect drill guide is used, there is potential for bone damage due to incorrectly placed drill holes for the implant included in the kit.
What to do
FDA enforcement status: Ongoing
Brands named
synthes usa productssynthessynthes usa
UPCs
00810633020166
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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