International safety notice
Medical institutions have confirmed that the arrangement of two holes provided for gripping with forceps during treatment using this product is not the same as previously used. We have received a report that the specifications are different from the product currently available. As a result of the investigation, it was discovered that the hole arrangement was 90° different due to a setting error in the machining program. Since the product differs from the approved items, we have decided to carry out a voluntary recall of the affected product.
Japan / PMDA Recalls · JPN · Nov 13, 2023
Key facts
| Title | Medical institutions have confirmed that the arrangement of two holes provided for gripping with forceps during treatment using this product is not the same as previously used. We have received a report that the specifications are different from the product currently available. As a result of the investigation, it was discovered that the hole arrangement was 90° different due to a setting error in the machining program. Since the product differs from the approved items, we have decided to carry out a voluntary recall of the affected product. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Artificial bone implant Brand name: Apacerum-C1 |
| Manufacturer | HOYA Technosurgical Co., Ltd. |
| Models | 17644910, 17089710, C1-013-TC-021-10, 17740310, 17644911, C1-013-TC-023-12 |
| Date | Nov 13, 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