Medtronic Korea said it has initiated a large-scale domestic recall of its natural bone graft products.

The company recalled Grafton DBM (model name: T45001INT) due to concerns about damage to the sterilization package exterior during the product packaging process of natural bone graft. There are 11,903 units in circulation in Korea, and the company recalled all products.

According to the company, it confirmed that the outer pouch and the inner pouch of the Grafton DBM product were produced outside the manufacturing specifications during a manufacturing inspection in February 2022.

As a result, Medtronic Korea began the voluntary recall due to concerns that the damage to the package exterior might have caused contamination of its natural bone graft.

“After further investigation, it was confirmed that the affected products were about 0.48 percent of the entire product batch,” a company spokesperson told Korea Biomedical Review. “While the percentage is very low, we decided to recall the products based on our high safety standards.”

There is no problem with the product itself, she added.

Natural bone graft refers to the bone for grafting developed to regenerate or restore bone defects.

The main component is powder processed from human bones, and collagen is used as an additive to apply the main component to the treated area.

The natural bone graft helps form new bone tissue while maintaining its shape for a certain time in the treated area.

Also, as the graft is inserted into the human body, the Ministry of Food and Drug Safety classifies it as a Class 4 medical device with high risk.

Due to the nature of the material, there is a risk of infection, so the regulators require the products to be packaged and distributed in a double sterilized pouch.

However, Medtronic said the risk of product contamination is only when both the internal and external sterilization barriers are breached.

Medtronic calculated that the probability of all sterile barriers being penetrated was less than 1 in 2.7 million cases.