International safety notice
KR LimaVit Liner (product number: 6532.54.811) for knee prosthesis tibial components I accidentally labeled the knee prosthesis tibial component "KR LimaVit Liner" (product number: 6532.54.714). It became clear that it had been attached. We have decided to voluntarily recall the product. In addition, after checking the manufacturing records, it was found that the legally required labels were affixed to these two products on the same day. Therefore, "KR LimaVit Liner" (product number: 6532.54.714) is replaced by "KR LimaVit Liner" (product number: 653). 2.54.811), so we conducted a voluntary recall of the two lots mentioned above. I decided to do it.
Japan / PMDA Recalls · JPN · Jul 27, 2023
Key facts
| Title | KR LimaVit Liner (product number: 6532.54.811) for knee prosthesis tibial components I accidentally labeled the knee prosthesis tibial component "KR LimaVit Liner" (product number: 6532.54.714). It became clear that it had been attached. We have decided to voluntarily recall the product. In addition, after checking the manufacturing records, it was found that the legally required labels were affixed to these two products on the same day. Therefore, "KR LimaVit Liner" (product number: 6532.54.714) is replaced by "KR LimaVit Liner" (product number: 653). 2.54.811), so we conducted a voluntary recall of the two lots mentioned above. I decided to do it. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Knee prosthesis tibial component (knee prosthesis patella component) Sales name: Physica KR LimaVit liner |
| Manufacturer | Nippon Lima Co., Ltd. |
| Models | 2111683, 2110719 |
| Date | Jul 27, 2023 |
| 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