Zimmer Biomet Recalls 1,300 Bone Growth and Spinal Fusion Stimulators

A recall that Zimmer Biomet initiated in February has just been identified by FDA as a Class I recall, marking it the most serious type of medical device recall. The company is recalling 1,360 implantable bone growth and spinal fusion stimulators that are used to help heal bone following spinal fusion surgery or to help heal broken long bones, such as a leg or arm bone. These devices are placed during surgery and are designed to send a low-level electrical signal to encourage the body's natural healing process. Several sessions at MD&M West 2019 will focus on regulatory and quality issues that impact medical device companies, including a session on preparing for FDA inspections in 2019. Don't miss this session and more, Feb. 5-7 in Anaheim, CA. Specifically, the recalled product is the company's Osteogen Implantable Bone Growth Stimulator, SpF Plus-Mini Implantable Fusion Stimulator, and the SpF-XL Implantable Spinal Fusion Stimulator. All serial numbers expiring before March 31, 2019 are affected, FDA said. The affected products were distributed between April 29, 2015 and March 31, 2018. The agency said Zimmer Biomet initiated the recall because of a lack of adequate validation and controls to ensure that final products were clean and free from bacteria and chemical residue. The lack of adequate validation and controls may or may not cause serious side effects for the patient including infection, tissue death, additional su...
Source: MDDI - Category: Medical Devices Authors: Tags: Regulatory and Compliance Source Type: news