International safety notice
This product is used for mixing bone cement and injecting it into the surgical site in orthopedic joint replacement surgery. Tighten and attach the screw-type nozzle for injecting into the predicate into the cylindrical cartridge container containing bone cement. Additionally, use a cement gun. It has a locking function that goes beyond the protruding bump on the cartridge. After receiving a report that the part tab does not go over the bump, we investigated and found that in some lots, the nozzle strut It was discovered that the product was manufactured using a mold that had a slight misalignment in the thread position of the upper tab and screw. Therefore, we cannot deny the possibility that the nozzle may not be locked properly when attached to the cartridge. We have decided to carry out a voluntary recall.
Japan / PMDA Recalls · JPN · Aug 15, 2023
Key facts
| Title | This product is used for mixing bone cement and injecting it into the surgical site in orthopedic joint replacement surgery. Tighten and attach the screw-type nozzle for injecting into the predicate into the cylindrical cartridge container containing bone cement. Additionally, use a cement gun. It has a locking function that goes beyond the protruding bump on the cartridge. After receiving a report that the part tab does not go over the bump, we investigated and found that in some lots, the nozzle strut It was discovered that the product was manufactured using a mold that had a slight misalignment in the thread position of the upper tab and screw. Therefore, we cannot deny the possibility that the nozzle may not be locked properly when attached to the cartridge. We have decided to carry out a voluntary recall. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common Name: Manual Orthopedic Cement Dispenser Brand name: Stryker bone cement injector (sterilized) |
| Manufacturer | Japan Striker Co., Ltd. |
| Models | 22349012, 22362012, 22320012, 22314012, OR-206-512-1, 22319012, 22313012, 22350012, 22337012, 22353012, 22326012, 22322012 and 8 more |
| Date | Aug 15, 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