International safety notice
We received a report from the market that a crimp failure was observed in the sealing part of sterile packaging, and an investigation into the incident was conducted. It was found that crimping defects occurred in the sealing parts of some products, which may affect the sterility of the products. In consideration of the impact on patients when a product affected by sterile conditions is used, we have decided to voluntarily recall the product. I did.
Japan / PMDA Recalls · JPN · Jan 17, 2022
Key facts
| Title | We received a report from the market that a crimp failure was observed in the sealing part of sterile packaging, and an investigation into the incident was conducted. It was found that crimping defects occurred in the sealing parts of some products, which may affect the sterility of the products. In consideration of the impact on patients when a product affected by sterile conditions is used, we have decided to voluntarily recall the product. I did. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Internal fixation cable Brand name: (1) Stainless steel cable (sterilized product) (2) Kinkless cable |
| Manufacturer | AimedicMMT Co., Ltd. |
| Models | F01-210519, KD2104A01L, TR006P, KD2103A01L, F01-210419, KD2011A01L, KD2102A01L, F01-201110, KD2104A02L, KD2101A01L, F01-210304, F01-210212 and 6 more |
| Date | Jan 17, 2022 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About International device safety notices
Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.
Source: National medical device regulators (as listed), compiled by Orca1