International safety notice
SCS screwdriver product number 046.401 (lot EHG85) and product number 046.402 (lot EHG85) from an overseas manufacturer. We have received multiple complaints from customers in various countries that the tip of the screwdriver (FAP78) does not fit into the screw hole. After investigating the complaint, we found that due to a manufacturing error, the tip of the screwdriver did not have the correct shape. It has been determined that the screw carrying system may not fit properly into the screw holes and may not function properly. We have received information from a foreign manufacturer that they will begin a voluntary recall of the affected products. We have decided to carry out a voluntary recall.
Japan / PMDA Recalls · JPN · May 26, 2021
Key facts
| Title | SCS screwdriver product number 046.401 (lot EHG85) and product number 046.402 (lot EHG85) from an overseas manufacturer. We have received multiple complaints from customers in various countries that the tip of the screwdriver (FAP78) does not fit into the screw hole. After investigating the complaint, we found that due to a manufacturing error, the tip of the screwdriver did not have the correct shape. It has been determined that the screw carrying system may not fit properly into the screw holes and may not function properly. We have received information from a foreign manufacturer that they will begin a voluntary recall of the affected products. We have decided to carry out a voluntary recall. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common Name: Dental Implant Surgical Instrument Brand name: Straumann implant manual tool |
| Manufacturer | Stroman Japan Co., Ltd. |
| Models | EHG85, CXV34, EGT63, FAP78, 046.402, 046.401 |
| Date | May 26, 2021 |
| 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