FDA (Devices) recall action 90918
The FDA (Devices) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Synthes is recalling SPEED 9X10X10mm surgical implant kits nationwide due to an incorrect-size drill guide that will not properly prepare bone for the implant, creating potential for bone damage.
Synthes (USA) Products LLC is recalling 196 DePuy Synthes Hammertoe Continuous Compression Implants due to an incorrect drill guide size that will not properly prepare bone for the implant, creating potential for bone damage.
Synthes (USA) Products LLC is recalling 81 SPEEDSHIFT20x20x20 Offset 10mm Implant Drill Kits nationwide due to incorrect drill guide sizing. The defect could result in bone damage and incorrectly placed drill holes during orthopedic surgery.
Synthes surgical implant kits are being recalled because they contain an incorrect size drill guide that cannot properly prepare the bone for the implant, creating a risk of bone damage during surgery.