Zimmer Biomet (NYSE:ZBH) issued an urgent safety notice concerning hip, knee and shoulder implants that could possibly adhere to the low density polyethylene bags they are packaged in.
According to the company, the highly polished implants can become attached to the LDPE bag, leaving residue from the bag attached to the devices which could interfere with procedures utilizing the devices.
The estimated rate of bag adhesions is 1 in every 12,800 cases, the company said.
Zimmer Biomet said that it is “unlikely” that the adhesion of the bag would cause an adverse effect to the patient or function of the implant, according to their field safety notice.
The company said the bags are biocompatible and similar to ultra high molecular weight polyethylene, and that the LDPE is softer than the 2 mating materials of UHMWPE and cobalt chrome molybdenum and not expected to scratch either wear surface.
The most serious consequences listed by the manufacturer was a possible delay in surgery between 10 and 30 minutes, with no long term health consequences expected.
The company said it notified local authorities, and requested that any products affected by the adhesion be returned. New bags that don’t have the issue are being used to package future products, Zimmer Biomet said.
The post Zimmer Biomet warns of packaging issue with hip, knee, shoulder implants appeared first on MassDevice.
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