International safety notice
21 products eligible for "Arthrex Ankle Fracture Plate Ti" (see 2. Target lots, quantities, and shipping dates) Therefore, the legal label should state "Arthrex Ankle Fracture Plate Ti" as the brand name. It has been discovered that it is listed as "Arthrex Ankle Fracture System Ti". Since the deviation was confirmed, we decided to voluntarily recall the product.
Japan / PMDA Recalls · JPN · Nov 10, 2021
Key facts
| Title | 21 products eligible for "Arthrex Ankle Fracture Plate Ti" (see 2. Target lots, quantities, and shipping dates) Therefore, the legal label should state "Arthrex Ankle Fracture Plate Ti" as the brand name. It has been discovered that it is listed as "Arthrex Ankle Fracture System Ti". Since the deviation was confirmed, we decided to voluntarily recall the product. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Internal fixation plate Sales name: Arthrex Ankle Fracture Plate Ti |
| Manufacturer | Arthrex Japan Contract Co., Ltd. |
| Models | 10514064, AR-9943BL-04S, 10202169, AR-9943C-10S, 10202165, 10514048, 11193543, 10623978, 12411840, AR-9943BL-06S, 10560415, AR-9943T-12S and 64 more |
| Date | Nov 10, 2021 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching catalog numbers in FDA data
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