International safety notice
This product is an artificial shoulder joint system (humerus side) that is used to reconstruct shoulder joint function when performing artificial joint replacement surgery. This is an implant used as a replacement material. Due to a communication from an overseas manufacturing facility, the hole diameter of the spigot bore, which is the stem fitting part, for a specific lot of products is below the standard. It turned out that it was manufactured in small dimensions. If the spigot bore is small, the stem and body components may not fit together, and the stem and body components may not fit together. Even when the components are mated, the fit may be so tight that it may be difficult to remove them. The dimensions differ from the specifications approved for manufacturing and sales, and the use of this product may result in an extension of surgery time, etc. Therefore, with an emphasis on patient safety, we have decided to carry out a voluntary recall.
Japan / PMDA Recalls · JPN · Dec 21, 2021
Key facts
| Title | This product is an artificial shoulder joint system (humerus side) that is used to reconstruct shoulder joint function when performing artificial joint replacement surgery. This is an implant used as a replacement material. Due to a communication from an overseas manufacturing facility, the hole diameter of the spigot bore, which is the stem fitting part, for a specific lot of products is below the standard. It turned out that it was manufactured in small dimensions. If the spigot bore is small, the stem and body components may not fit together, and the stem and body components may not fit together. Even when the components are mated, the fit may be so tight that it may be difficult to remove them. The dimensions differ from the specifications approved for manufacturing and sales, and the use of this product may result in an extension of surgery time, etc. Therefore, with an emphasis on patient safety, we have decided to carry out a voluntary recall. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Prosthetic glenohumeral component Sales name: Artificial shoulder joint system Global Unite |
| Manufacturer | Johnson & Johnson Co., Ltd. |
| Models | 9802277, 9824331, 9851812, 9802131, 1100-16-100, 9833538, 9802200, 9772229, 9802197, 1100-08-100, 9802274, 9772100 and 13 more |
| Date | Dec 21, 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