International safety notice
This product (hereinafter referred to as the trial) is used to check joint movement during artificial joint replacement surgery using the Mako system. The product is reusable and can be temporarily attached to and removed from the bone resection site using a femoral trial slap hammer. It is a manual surgical instrument. A report was made saying, “Yes.” The inner diameter of the trial's extraction hole, which is the part that connects to the trial, may be smaller than the standard. It has become clear. As we cannot deny the nature of the incident, we have decided to carry out a voluntary recall of the affected products.
Japan / PMDA Recalls · JPN · Jul 27, 2021
Key facts
| Title | This product (hereinafter referred to as the trial) is used to check joint movement during artificial joint replacement surgery using the Mako system. The product is reusable and can be temporarily attached to and removed from the bone resection site using a femoral trial slap hammer. It is a manual surgical instrument. A report was made saying, “Yes.” The inner diameter of the trial's extraction hole, which is the part that connects to the trial, may be smaller than the standard. It has become clear. As we cannot deny the nature of the incident, we have decided to carry out a voluntary recall of the affected products. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Joint surgical instruments Sales name: Mako MCK Instruments (*) |
| Manufacturer | Japan Striker Co., Ltd. |
| Models | 170417, 170504, 170418, 2915791, 170414, 170505, 170502, 170513, 170413, 170406, 170403, 2917041 and 33 more |
| Date | Jul 27, 2021 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 10–99 Matching device models in FDA data
- 10–99 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