Device recall
Z-1115-2015: GemLock Long Hex Driver, Catalog RHL2.5; Also distributed within the Tapered…
FDA device recall · Class II · Zimmer Dental Inc
Key facts
| Recall number (Z-number) | Z-1115-2015 |
|---|---|
| Recall event | 70304 |
| Product | GemLock Long Hex Driver, Catalog RHL2.5; Also distributed within the Tapered SwissPlus & SwissPlus Implant Systems Kits, Surgical, Complete, Catalog OPCST; Tapered Screw-Vent Implant System Surgical Kit, Complete, Catalog TSVKIT. Used as a manual delivery tool that engages the Fixture Mount Transfer… |
| Product code | NDP |
| Recalling firm | Zimmer Dental Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 3, 2015 |
| FEI number | 1038806 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database