Implants & Prosthetics

A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was advanced prematurely as a result of the machined component being stored in a transparent container exposed to artificial light for six years prior to inert packaging and sterilization of the device.

A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was advanced prematurely as a result of the machined component being stored in a transparent container exposed to artificial light for six years prior to inert packaging and sterilization of the device.

A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was advanced prematurely as a result of the machined component being stored in a transparent container exposed to artificial light for six years prior to inert packaging and sterilization of the device.

A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was advanced prematurely as a result of the machined component being stored in a transparent container exposed to artificial light for six years prior to inert packaging and sterilization of the device.

A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was advanced prematurely as a result of the machined component being stored in a transparent container exposed to artificial light for six years prior to inert packaging and sterilization of the device.

A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was advanced prematurely as a result of the machined component being stored in a transparent container exposed to artificial light for six years prior to inert packaging and sterilization of the device.

A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was advanced prematurely as a result of the machined component being stored in a transparent container exposed to artificial light for six years prior to inert packaging and sterilization of the device.

A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was advanced prematurely as a result of the machined component being stored in a transparent container exposed to artificial light for six years prior to inert packaging and sterilization of the device.

Certain modules containing the Synthes Small Notch Titanium Reconstructive Plate set was distributed by Spine sales consultants although it was contraindicated for certain spine applications.

DePuy Orthopaedics has identified the potential for holes to develop in the inner and outer flexible pouches that form the sterile barrier for S-ROM Noiles Rotating Hinge Femur with Pin devices. The outer carton and shrink wrap are intact. A package redesign is underway to resolve this issue. S-ROM Noiles Rotating Hinge Femur with Pin devices will remain in US Distributors inventory during the pa

DePuy Orthopaedics has identified the potential for holes to develop in the inner and outer flexible pouches that form the sterile barrier for S-ROM¿ Noiles Rotating Hinge Femur with Pin devices. The outer carton and shrink wrap are intact. A package redesign is underway to resolve this issue. S-ROM Noiles Rotating Hinge Femur with Pin devices will remain in US Distributors inventory during the p

DePuy Orthopaedics has identified the potential for holes to develop in the inner and outer flexible pouches that form the sterile barrier for S-ROM¿ Noiles Rotating Hinge Femur with Pin devices. The outer carton and shrink wrap are intact. A package redesign is underway to resolve this issue. S-ROM Noiles Rotating Hinge Femur with Pin devices will remain in US Distributors inventory during the p

DePuy Orthopaedics has identified the potential for holes to develop in the inner and outer flexible pouches that form the sterile barrier for S-ROM¿ Noiles Rotating Hinge Femur with Pin devices. The outer carton and shrink wrap are intact. A package redesign is underway to resolve this issue. S-ROM Noiles Rotating Hinge Femur with Pin devices will remain in US Distributors inventory during the

DePuy Orthopaedics has identified the potential for holes to develop in the inner and outer flexible pouches that form the sterile barrier for S-ROM Noiles Rotating Hinge Femur with Pin devices. The outer carton and shrink wrap are intact. A package redesign is underway to resolve this issue. S-ROM Noiles Rotating Hinge Femur with Pin devices will remain in US Distributors inventory during the pa

DePuy Orthopaedics has identified the potential for holes to develop in the inner and outer flexible pouches that form the sterile barrier for S-ROM Noiles Rotating Hinge Femur with Pin devices. The outer carton and shrink wrap are intact. A package redesign is underway to resolve this issue. S-ROM Noiles Rotating Hinge Femur with Pin devices will remain in US Distributors inventory during the pa

The product may be mislabeled and could result in the incorrect implant being used.

Packaging error -- two different types and sizes of acetabular liners used during hip replacement surgery were mistakenly packaged into each other's outer boxes after sterilization, resulting in the products being mislabeled. The units labeled as Model/Catalog Number 931-28-248 Lot/Serial Number 685F1034 on the outside and containing Model/Catalog Number 932-36-252, Lot# 728F1089 on the inside (1

Certain Silicone TECNIS IOLs may be labeled with the incorrect diopter power.

Greatbatch Medical has initiated a global Field Corrective Action for the Standard Offset Cup Impactor since the product was first released in 2004. Greatbatch has identified through internal Sterility Assurance Level validation testing that a sterility assurance level of 10-6 is not achieved on the Standard Offset Cup Impactor when it is subjected to the steam sterilization cycles and associated dry times that are specified in the current Instructions For Use (IFU) provided with the device. The Standard Offset Cup Impactor is provided non-sterile and must be sterilized prior to use in a surgery. Greatbatch has not received any reports of deaths, illnesses, injuries, or other adverse effects associated with this issue.

Knee implant femoral devices were found to have anomalous microstructure. Porosity and the presence of blocky carbides, within the cobalt chrome part, can decrease the overall fatigue strength. This decrease in strength could cause implants to fracture under what would normally be acceptable loads.