International safety notice
It has been confirmed that a product with an incorrect legal label has been placed on the market. Based on the construction records, the legal label affixed to the product indicates that the in-bone length of the implant is 12 mm for a product with an 8 mm in-bone implant length. It has been confirmed that the 8mm bone implant length of Runt was attached to a 12mm product, so we will recall the lot. In addition, products with an 8 mm label attached to products with an implant length of 12 mm will not be shipped to the market. However, some products with a label of 12 mm attached to the implant have an 8 mm in-bone implant length. We have confirmed that the product has been shipped to customers, and the destination has been specified.
Japan / PMDA Recalls · JPN · May 15, 2023
Key facts
| Title | It has been confirmed that a product with an incorrect legal label has been placed on the market. Based on the construction records, the legal label affixed to the product indicates that the in-bone length of the implant is 12 mm for a product with an 8 mm in-bone implant length. It has been confirmed that the 8mm bone implant length of Runt was attached to a 12mm product, so we will recall the lot. In addition, products with an 8 mm label attached to products with an implant length of 12 mm will not be shipped to the market. However, some products with a label of 12 mm attached to the implant have an 8 mm in-bone implant length. We have confirmed that the product has been shipped to customers, and the destination has been specified. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: dental implant fixture Brand name: Straumann Implant (SLA Loxim) TL |
| Manufacturer | Stroman Japan Co., Ltd. |
| Models | 043.928S, PZL55, 043.926S, RNN55 |
| Date | May 15, 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