Synthes (USA) Products LLC: SPEED 9X10X10mm Continuous Compression Implant, Product No. SE-0910

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.

Details from the source

Reason for recall: 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. Distribution: US Nationwide distribution. Quantity: 96 Lot/code info: UDI-DI (GTIN): 00810633020111 Lot/Expiry MSE210240 7/1/2027

UPC codes

00810633020111

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.