ZIMMER RECALLS M/L TAPER HIP STEMS AND NECKS (Orthopedics This Week)
On June 8, 2015, Zimmer Inc. initiated a Class I Recall of its M/L Taper with Kinectiv Technology Femoral Stems and Necks.
Manufacturing Residue
Due to a process monitoring failure, higher-than-expected amounts of manufacturing residues were left on the devices made from March 31, 2015 through April 20, 2015. The residues can cause "serious adverse health issues including allergic reactions, pain, infections, or death. Use of these products may require the need for a revision surgery to replace the affected implant," according to the company.
The stems and necks are Tivanium alloy implants used for hip replacements that allow the surgeon to fit the implant specifically to the patient.
According to the FDA, Zimmer issued recall notification letters and instructions for distributors and hospital staff on May 18, 2015.
Recall Instructions
The following instructions were given to distributors:
“Review the notification and ensure affected personnel are aware of the contents.”
“Locate all affected product identified in the recall letter and quarantine them immediately.”
“Carry out a physical count of all affected produ...
