FDA Device recall Z-1115-2015
GemLock Long Hex Driver, Catalog RHL2.5
- FDA Device
- Class II
- terminated
- Published 2015-02-18
On 2015-02-18 the FDA classified a Class II recall of GemLock Long Hex Driver, Catalog RHL2.5 by Zimmer Dental, citing the Gemlock Long Hex Driver may not fit into the Fixture Mount Transfer (FMT) or the internal hex of the implant.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1115-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-01-22 |
| Published | 2015-02-18 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Zimmer Dental |
| Distribution | n/a |
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 (FMT) to transport the dental implant from the product packaging to the osteotomy.
Reason
The Gemlock Long Hex Driver may not fit into the Fixture Mount Transfer (FMT) or the internal hex of the implant.
Identifiers
| code_info | Etched Lot No. 62699693 & 62735177. Lot Number on Label: 62712431, 62743168, 62766610, 62702589, 62710484, 62712437, 6…Etched Lot No. 62699693 & 62735177. Lot Number on Label: 62712431, 62743168, 62766610, 62702589, 62710484, 62712437, 62743075, 62750487, 62753787, 62756920, 62759862, 62760388, 62768456, and 62773158. Expanded Lot No. 62728173. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Other recalls by Zimmer Dental
- Outer Package Label: Tapered Screw-Vent Implant System, 4.1mm X 10mm, 3.5mm, REF:TSVM4B10, Sterile:R, Rx Only
FDA Device · Class II · 2018-09-12 · Zimmer Dental - Tapered Screw-Vent MTX, Dental Implant, sterile
FDA Device · Class II · 2018-04-04 · Zimmer Dental - Tapered Screw-Vent MTX, Dental Implant, sterile
FDA Device · Class II · 2018-04-04 · Zimmer Dental - Zimmer Dental Tapered SwissPlus & SwissPlus Implant Systems surgical kit, Ref OPCST. The label shows the product is Manufactured by Zimmer…
FDA Device · Class II · 2017-12-27 · Zimmer Dental - Tapered Screw-Vent MTX Model TSVTB11
FDA Device · Class II · 2017-12-27 · Zimmer Dental
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1115-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.