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Synthes (USA) Products LLC recalls SPEED 15X12X12mm Continuous Compression Implant, Product No. SE-1512
Recalled October 26, 2022 · FDA recall Z-0099-2023 · Synthes (USA) Products
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. · FDA Class II
Units
94 US; 30 OUS
Sold at
US Nationwide distribution.
Description
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.
Product
SPEED 15X12X12mm Continuous Compression Implant, Product No. SE-1512
Manufacturer(s)
Synthes (USA) Products LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →