FDASeptember 27, 2022device

SPEEDSHIFT20x20x20 Offset 10mm Implant Drill Kit, Product No. SE-2020-10. Used with DePuy Synthes SPEEDSHIFT Continuous Compression Staple Implants for bone fixation and management of fracture and reconstructive surgery.

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

00810633020494

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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