International safety notice
The diameter of the tip of the NEXTRA Sterile Instrument: Driver for the proximal phalanx implant is slightly larger than the dimensional tolerance. We will carry out a recall as there is a lot that is being manufactured too slowly.
Japan / PMDA Recalls · JPN · Feb 24, 2022
Key facts
| Title | The diameter of the tip of the NEXTRA Sterile Instrument: Driver for the proximal phalanx implant is slightly larger than the dimensional tolerance. We will carry out a recall as there is a lot that is being manufactured too slowly. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: (1) Internal fixation screw (2) Single-use bone surgery instrument Sales name: (1)Nextra Hammertoe System (2)Nextremity single-use instrument |
| Manufacturer | Zimmer Biomet LLC |
| Models | 168A27917C, 168125017D, 168125017B, NX-3532K-SC, NX-4532K-SC |
| Date | Feb 24, 2022 |
| 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