CLASS II Device recall · Reported 27 Dec 2017 · FDA Enforcement Report
GemLock RHD2.5 Hex Driver recalled by Zimmer Dental
Zimmer Dental is recalling GemLock RHD2.5 Hex Driver, distributed nationwide in the US. The recall was initiated on 11 Oct 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0279-2018
- FDA event ID
- 78321
- Recalling firm
- Zimmer Dental, Carlsbad, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Oct 2017
- FDA classified
- 21 Dec 2017
- Reported
- 27 Dec 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Dental Devices
Timeline
| 11 Oct 2017 | Recall initiated by company | |
| 21 Dec 2017 | Classified by FDA | +71 days |
| 27 Dec 2017 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The device may contain a manufacturing condition affecting the geometry of the driver's hex feature which prevents it from properly engaging the fixture mount transfer and/or a dental implant.
Product as listed by the FDA
Zimmer Dental GemLock RHD2.5 Hex Driver. The label shows the product is Manufactured by Zimmer Dental Inc., Carlsbad, CA. Endosseous dental implant accessories are manually powered devices intended to aid in the placement or removal of endosseous dental implants and abutments, prepare the site for placement of endosseous dental implants or abutments, aid in the fitting of endosseous dental implants or abutments, aid in the fabrication of dental prosthetics, and be used as an accessory with endosseous dental implants when tissue contact will last less than 1 hour.
Where it was distributed
Worldwide Distribution: US (nationwide) and countries of: Canada, Australia, Belgium, Bulgaria, Chile, Costa Rica, Egypt, France, Georgia, Germany, Hong Kong, Hungary, Iran, Ireland, Israel, Italy, Japan, Lebanon, Lithuania, Netherlands, Nicaragua, Poland, Portugal, Romania, Serbia, Shanghai, Spain, Taiwan, Thailand, Tunisia, Turkey, UK, and United Arab Emirates.
Questions about this recall
Why was it recalled?
The device may contain a manufacturing condition affecting the geometry of the driver's hex feature which prevents it from properly engaging the fixture mount transfer and/or a dental implant.
Which lots are affected?
Lot numbers 63563072, 63572755, 63583270, and 63755802
Where was it sold?
Worldwide Distribution: US (nationwide) and countries of: Canada, Australia, Belgium, Bulgaria, Chile, Costa Rica, Egypt, France, Georgia, Germany, Hong Kong, Hungary, Iran, Ireland, Israel, Italy, Japan, Lebanon, Lithuania, Netherlands, Nicaragua, Poland, Portugal, Romania, Serbia, Shanghai, Spain, Taiwan, Thailand, Tunisia, Turkey, UK, and United Arab Emirates.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 78321| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Tapered SwissPlus & SwissPlus Implant Systems surgical kit recalled | Zimmer Dental | Other | Nationwide | |
| CLASS II | Instrument Kit System, Tapered Screw-Vent Implant System recalled | Zimmer Dental | Other | Nationwide | |
| CLASS II | Instrument Kit System, Tapered Screw-Vent Implant System recalled | Zimmer Dental | Other | Nationwide |
More recalls from Zimmer Dental
All 33| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Outer Package Label: Tapered Screw-Vent Implant System recalled | Zimmer Dental | Packaging Defects | Nationwide |
| Device | CLASS II | Tapered Screw-Vent MTX, Dental Implant, sterile recalled | Zimmer Dental | Labeling Errors | Nationwide |
| Device | CLASS II | Tapered Screw-Vent MTX, Dental Implant, sterile recalled | Zimmer Dental | Labeling Errors | Nationwide |
| Device | CLASS II | Instrument Kit System, Tapered Screw-Vent Implant System recalled | Zimmer Dental | Other | Nationwide |
| Device | CLASS II | Instrument Kit System, Tapered Screw-Vent Implant System recalled | Zimmer Dental | Other | Nationwide |
Other Dental Devices recalls
All 426| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Grandio Universal Nano-Hybrid Restorative Material - Capsules 0.25Gm recalled | Henry Schein | Packaging Defects | Nationwide |
| Device | CLASS II | GM Helix Implant, Endosseous Dental Implant Article No. recalled | Straumann USA | Packaging Defects | Nationwide |
| Device | CLASS II | KL Owen Custom Orthodontic Solution recalled by Klowen Braces | Klowen Braces | Device Malfunction | Nationwide |
| Device | CLASS II | Straumann n!ce PMMA Full-arch Restoration recalled | Straumann USA | Other | 8 states |
| Device | CLASS II | Straumann n!ce Zr, HT, Full-arch Restoration recalled | Straumann USA | Other | 8 states |