[Recalled] Metalogix Self-Drill Half-Pin, a component of the Revolution External Fixation System. Orthopedic. Metalogix Self-Drill Half-Pin 5x30x215mm REF 620030 Metalogix Self-Drill Half-Pin 5x40x215mm REF 620040 Metalogix S
Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.
Recall details
| Product | Metalogix Self-Drill Half-Pin, a component of the Revolution External Fixation System. Orthopedic. Metalogix Self-Drill Half-Pin 5x30x215mm REF 620030 Metalogix Self-Drill Half-Pin 5x40x215mm REF 620040 Metalogix Self-Drill Half-Pin 5x60x215mm REF 620060 Metalogix Self-Drill Half |
|---|---|
| Brand / manufacturer | New Standard Device Inc |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1649-2022 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 28 December 2020 |
| EAN / barcode | 854641008198 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: Complaints were received for Self-drill Half-Pin tip breakages occurring during surgery.
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from New Standard Device Inc
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.
- Qu'est-ce que 1,2,4-Trichlorobenzene (CAS 120-82-1) ? Sécurité, réglementation & perspective UE/États-Unis/Canada | ProductGuru
- Exhibitions Expiry and Shelf Life: A Complete Guide
- Was ist 2,2'-dichloro-4,4'-methylenedianiline (CAS 101-14-4)? Sicherheit, Regulierung & Perspektive EU/USA/Kanada | ProductGuru
- Was ist 2-(2H-benzotriazol-2-yl)-4,6-ditertpentylphenol (UV-328) (CAS 25973-55-1)? Sicherheit, Regulierung & Perspektive EU/USA/Kanada | ProductGuru
- The Hidden Truth About Automotive Accessories Expiry and Shelf Life: What You Need to Know
- Was ist 2-(4-tert-butylbenzyl)propionaldehyde and its individual stereoisomers? Sicherheit, Regulierung & Perspektive EU/USA/Kanada | ProductGuru