Zimmer Recalled Devices Due To Manufacturing Residues. Zimmer, Inc. has recalled lots of the Zimmer M/L Taper with Kinectiv Technology Femoral Stems and Neck after finding higher than expected amounts of manufacturing residues left on the devices. The residues can cause serious adverse health consequences including allergic reactions, pain, infections, or death.
Use of these products may require the patient to under revision surgery to replace the affected implant, according to the Food and Drug Administration (FDA). The recalled devices were distributed from March 31, 2015 through April 20, 2015.
The Zimmer M/L Taper with Kinectiv Technology Femoral Stems and Necks are Tivanium alloy implants used for hip replacements that allow the surgeon to fit the implant specifically to the patient. During hip replacement surgery, damaged portions of the hip joint are removed and replaced with an integrated system of products, which includes the femoral stem and neck.
A full list of the recalled devices is posted on FDA web site. The manufacturer has not received any complaints related to this issue for any of the lots in distribution.
Zimmer Issued Letters And Instructions To Customers
On May 18, 2015, Zimmer issued recall notification letters and instructions for customers. Zimmer said facilities should locate all affected products and quarantine them immediately. Distributors should complete an Inventory Return Certification Form and then return the recalled product to Zimmer along with the completed Inventory Return Certification Form. Zimmer asks hospitals to identify surgeons who have implanted these devices so they can be contacted to monitor patients.
Customers with questions should contact Zimmer’s customer call center at 1-877-946-2761 between 8:00 am and 5:00pm EST.
This is a Class I recall, the most serious recall category. The FDA reserves Class I for situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death. The FDA encourages health care professionals and consumers to report adverse reactions or quality problems through the MedWatch Adverse Event Reporting program online, by mail, or by fax.
Zimmer may not be the only manufacturer with residue issues, Qmed reports. John Bolinder, vice president of marketing and communications at Nelson Laboratories in Salt Lake City, explains that the machining and milling or orthopedic implants is a messy process. Metal shavings can fly off during the process and devices are coated with an aqueous or oil-based residue in the machining process. Devices pick up other contaminants including microbiological and particulate debris. Failure to thoroughly clean off manufacturing residues and contaminants can cause serious problems for patients, Bolinder says. He noted a case in which a patient died of a stroke two weeks after receiving a metal knee implant. The patient suffered “complications including infection and particulates coming off the device, entering the cardiovascular system and ultimately causing his heart to stop,” Bolinder said. It is imperative that surgeons know that implantable devices have been thoroughly cleaned after manufacturing, according to Qmed.