International safety notice
A medical institution has informed us that during treatment using this product, the screw part of the plate into which the screw is inserted is different from the product. We received a report that it was installed. As a result of the investigation, it was discovered that the product had been shipped with a jig used to protect the screw holes during the manufacturing process still attached. did. Because a jig that should be removed during the manufacturing process was shipped, we cannot deny the possibility that a similar event may occur. We have decided to carry out a voluntary recall of the products.
Japan / PMDA Recalls · JPN · Mar 17, 2023
Key facts
| Title | A medical institution has informed us that during treatment using this product, the screw part of the plate into which the screw is inserted is different from the product. We received a report that it was installed. As a result of the investigation, it was discovered that the product had been shipped with a jig used to protect the screw holes during the manufacturing process still attached. did. Because a jig that should be removed during the manufacturing process was shipped, we cannot deny the possibility that a similar event may occur. We have decided to carry out a voluntary recall of the products. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Compression hip plate for internal fixation Brand name: Obry Locking Hip Screw System |
| Manufacturer | HOYA Technosurgical Co., Ltd. |
| Models | 2199LQ, 2199KX, 22A9MB, 2179KV, 22C9JR, 2189LD, 2179KU, 22B9HE, 2189LB, 22A9KN, 2189LH, 2179GW and 11 more |
| Date | Mar 17, 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