International safety notice
During work at a domestic registered manufacturing facility, it was discovered that two products had the wrong legal labels affixed to them. One was used for surgery, and a product that was 4 mm longer than the planned size was implanted into the patient, but the size had no effect. The surgery has been completed. These are the only two products (sold name: TM Ardis cage) that have been confirmed to have been labeled incorrectly, but we are taking all possible precautions. Therefore, we have decided to voluntarily recall products currently on the market that have undergone similar procedures. We will conduct patient monitoring for patients who have used a product of a different size than the intended size due to incorrect pasting of the product. vinegar.
Japan / PMDA Recalls · JPN · May 15, 2023
Key facts
| Title | During work at a domestic registered manufacturing facility, it was discovered that two products had the wrong legal labels affixed to them. One was used for surgery, and a product that was 4 mm longer than the planned size was implanted into the patient, but the size had no effect. The surgery has been completed. These are the only two products (sold name: TM Ardis cage) that have been confirmed to have been labeled incorrectly, but we are taking all possible precautions. Therefore, we have decided to voluntarily recall products currently on the market that have undergone similar procedures. We will conduct patient monitoring for patients who have used a product of a different size than the intended size due to incorrect pasting of the product. vinegar. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: (1)(3)(5)Intraspinal fixation device (2)(4)(6)Spine cage Sales name: (1)Lineum CoCr rod system (2)ROI-C Ti-Coated PEEK Spinal Cage (3) MaxAn Interior Cervical Plate System (4) ZYSTON curve spacer (5) Universal clamp (6)TM Ardis cage |
| Manufacturer | Jinvi Japan LLC |
| Models | J7284895, 14-521620E, 85025, 14-521618E, 14-524212E, 14-533128, 086437, 14-521616E, J3393904, 14-521650E, 85269, J6885680 and 59 more |
| Date | May 15, 2023 |
| 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