Table 3 Reasons of osteosynthesis implant and joint replacement implant recalls in China, America, Canada and Australia
Recalls | Process control | Packaging process control | Mislabeled | Nonconforming material or component | Clinical application | Device design | Supervising process control | Instruction design | Mix-up of material or component | Process design | Others | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Osteosynthesis implant | Total | NO | 56 | 54 | 52 | 44 | 34 | 33 | 23 | 8 | 4 | 3 | 4 |
P (%) | 17.78 | 17.14 | 16.51 | 13.97 | 10.79 | 10.48 | 7.30 | 2.54 | 1.27 | 0.95 | 1.27 | ||
China | NO | 20 | 14 | 22 | 20 | 4 | 0 | 6 | 2 | 2 | 1 | 2 | |
P (%) | 21.51 | 15.05 | 23.66 | 21.51 | 4.30 | 0.00 | 6.45 | 2.15 | 2.15 | 1.08 | 2.15 | ||
America | NO | 10 | 2 | 11 | 9 | 6 | 17 | 7 | 1 | 1 | 2 | 1 | |
P (%) | 14.93 | 2.99 | 16.42 | 13.43 | 8.96 | 25.37 | 10.45 | 1.49 | 1.49 | 2.99 | 1.49 | ||
Canada | NO | 12 | 12 | 5 | 9 | 11 | 9 | 7 | 1 | 1 | 0 | 0 | |
P (%) | 17.91 | 17.91 | 7.46 | 13.43 | 16.42 | 13.43 | 10.45 | 1.49 | 1.49 | 0.00 | 0.00 | ||
Australia | NO | 14 | 17 | 14 | 6 | 13 | 7 | 3 | 4 | 0 | 0 | 0 | |
P (%) | 17.95 | 21.79 | 17.95 | 7.69 | 16.67 | 8.97 | 3.85 | 5.13 | 0.00 | 0.00 | 0.00 | ||
Joint replacement implant | Total | NO | 42 | 62 | 47 | 38 | 40 | 25 | 13 | 5 | 5 | 2 | 7 |
P (%) | 14.69 | 21.68% | 16.43 | 13.29 | 13.99 | 8.74 | 4.55 | 1.75 | 1.75 | 0.70 | 2.45 | ||
China | NO | 15 | 27 | 28 | 10 | 3 | 7 | 4 | 2 | 3 | 1 | 4 | |
P (%) | 14.42 | 25.96 | 26.92 | 9.62 | 2.88 | 6.73 | 3.85 | 1.92 | 2.88 | 0.96 | 3.85 | ||
America | NO | 10 | 17 | 8 | 9 | 9 | 9 | 6 | 0 | 0 | 0 | 0 | |
P (%) | 14.71 | 25.00 | 11.76 | 13.24 | 13.24 | 13.24 | 8.82 | 0.00 | 0.00 | 0.00 | 0.00 | ||
Canada | NO | 10 | 12 | 4 | 8 | 7 | 3 | 2 | 1 | 2 | 0 | 1 | |
P (%) | 20.00 | 24.00 | 8.00 | 16.00 | 14.00 | 6.00 | 4.00 | 2.00 | 4.00 | 0.00 | 2.00 | ||
Australia | NO | 7 | 6 | 7 | 11 | 21 | 6 | 1 | 2 | 0 | 1 | 2 | |
P (%) | 10.94 | 9.38 | 10.94 | 17.19 | 32.81 | 9.38 | 1.56 | 3.13 | 0.00 | 1.56 | 3.13 | ||