Aesculap Inc. US has initiated a recall on Tibial and Femur extension sterile pressfit stem implant packaging that are used for Columbus Revision/Enduro Knee Implants because it is labeled as Cementless. US product is indicated in the US for use with Bone Cement only.
Implants & Prosthetics
🏥 Medical Devices • 4,589 recalls
Reports where the Mylar/Tyvek pouch for RESTORIS MCK Baseplate in the clamshell packaging configuration exhibited damage, compromising the sterile barrier.
LDPE bag containing the implant adheres to the highly polished implant surface.
LDPE bag containing the implant adheres to the highly polished implant surface.
LDPE bag containing the implant adheres to the highly polished implant surface.
LDPE bag containing the implant adheres to the highly polished implant surface.
LDPE bag containing the implant adheres to the highly polished implant surface.
LDPE bag containing the implant adheres to the highly polished implant surface.
LDPE bag containing the implant adheres to the highly polished implant surface.
LDPE bag containing the implant adheres to the highly polished implant surface.
LDPE bag containing the implant adheres to the highly polished implant surface.
LDPE bag containing the implant adheres to the highly polished implant surface.
LDPE bag containing the implant adheres to the highly polished implant surface.
LDPE bag containing the implant adheres to the highly polished implant surface.
LDPE bag containing the implant adheres to the highly polished implant surface.
LDPE bag containing the implant adheres to the highly polished implant surface.
A complaint was received where the Hiploc Plate/Lag Screw Introducer was undersized and would not accept the introducor coupling screw. It appears now that not all parts manufactured to Rev A drawing were reworked.
LDPE bag containing the implant adheres to the highly polished implant surface.
LDPE bag containing the implant adheres to the highly polished implant surface.
LDPE bag containing the implant adheres to the highly polished implant surface.