Table 1 The definitions of the reasons for each recall

Clinical application

Due to some defects in the product

 1. The operation is delayed or failed

 2. The rate of recurrence or reoperation is increased

Supervising process control

The problems are found during the supervisory process

Device design

Due to the product design error

 1. There are difficulties in the later production and manufacturing process (The Technology does not meet the requirements of the product size)

 2. The product does not achieve the expected therapeutic effect in clinical application

Instruction design

Including

 1. The contents of the instruction are wrong

 2. The instruction does not match the products

 3. The instruction is updated

Mislabeled

Including

 1. The content on the label is wrong

 2. The label does not match the product

 3. The label is missing

Mix-up of material or component

The mix-up of different types of materials or components exists

Nonconforming material or component

Unqualified materials or components are used in the production process, including impure materials and errors in size, thickness, roughness of components, etc.

Packaging process control

Due to the packaging process error

 1. There is packaging error, including omission or mix-up

 2. The product packaging bag is poorly sealed

 3. The sterile barrier is destroyed

Process control

Errors in production process result in unqualified and missing components or assembly errors

Process design

 1. Production process design is mistaken

 2. Some production or verification processes are missing

Others

Other reasons for not being classified