Synthes (USA) Products LLC: DePuy Synthes Hammertoe Continuous Compression Implants, Product No. 46.239.001

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: 196 Lot/code info: UDI-DI (GTIN): 00810633022047 Lot/Expiry MHC200114 2/9/2026 MHC220117 3/2/2027

UPC codes

00810633022047

Source

Official record: FDA (Device enforcement) ↗

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