International safety notice
The artificial hip joint femoral stem "Master SL Lateralized" (product number: 3516.21.260) was accidentally inserted into the artificial hip joint. The legal display label of "Modulus R Stem" (product number: 4330.15.220) was affixed to the arthrofemoral stem. has become clear. I decided to collect the main item. 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, the legal display label of "Master SL Lateralized" is attached to "Modulus R Stem". We cannot deny this possibility and have decided to voluntarily recall the "Modulus R Stem" as well.
Japan / PMDA Recalls · JPN · Jun 22, 2023
Key facts
| Title | The artificial hip joint femoral stem "Master SL Lateralized" (product number: 3516.21.260) was accidentally inserted into the artificial hip joint. The legal display label of "Modulus R Stem" (product number: 4330.15.220) was affixed to the arthrofemoral stem. has become clear. I decided to collect the main item. 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, the legal display label of "Master SL Lateralized" is attached to "Modulus R Stem". We cannot deny this possibility and have decided to voluntarily recall the "Modulus R Stem" as well. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Prosthetic hip femoral component Sales name: (1) Master SL (2) Modulus R stem |
| Manufacturer | Nippon Lima Co., Ltd. |
| Models | 2302246, 2303207 |
| Date | Jun 22, 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