Synthes (USA) Products LLC: SPEED 15X12X12mm Continuous Compression Implant, Product No. SE-1512

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: 94 US; 30 OUS Lot/code info: UDI-DI (GTIN): 00810633020166 Lot/Expiry MSE220445 7/1/2027 MSE210184 8/1/2026

UPC codes

00810633020166

Source

Official record: FDA (Device enforcement) ↗

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