International safety notice
The U.S. manufacturer received a request from its supplier regarding the plastic washer installed inside the instrument. We have received a report that a material different from the specifications was used, and we have decided to recall the entire production lot. Ta.
Japan / PMDA Recalls · JPN · Oct 18, 2021
Key facts
| Title | The U.S. manufacturer received a request from its supplier regarding the plastic washer installed inside the instrument. We have received a report that a material different from the specifications was used, and we have decided to recall the entire production lot. Ta. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | General name: Instruments for bone surgery Sales name: Original Ilizarov system surgical instruments |
| Manufacturer | Smith & Nephew Co., Ltd. |
| Models | 20LP02813, 21BP00272, 21BP00271, 20LP02817, 20LP02812, 71070341, 20LP02816, 20MP03124, 20LP02827 |
| Date | Oct 18, 2021 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models in FDA data
- 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