The Recall Desk
ModerateFDA (Devices)·Z-1115-2015·Announced 2015-02-18

Zimmer Dental Recalls GemLock Long Hex Driver Due to Fit Issues

Zimmer Dental Inc is recalling 627 GemLock Long Hex Drivers because they may not fit into the Fixture Mount Transfer or the implant's internal hex.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a functional defect (fit issue) without reporting any injuries, illnesses, or deaths. This aligns with the rubric for moderate severity involving low-risk contamination or functional defects without reported harm.

Plain-English summary

Zimmer Dental Inc is recalling 627 units of the GemLock Long Hex Driver (Catalog RHL2.5). This product is also distributed within the Tapered SwissPlus & SwissPlus Implant Systems Kits, Surgical, Complete (Catalog OPCST) and the Tapered Screw-Vent Implant System Surgical Kit, Complete (Catalog TSVKIT). The driver is used as a manual delivery tool to transport dental implants from packaging to the osteotomy site.

The recall was initiated because the GemLock Long Hex Driver may not fit into the Fixture Mount Transfer (FMT) or the internal hex of the implant. This potential fit issue could affect the proper use of the manual delivery tool during surgical procedures.

The affected units were distributed worldwide, including in the US, Argentina, Australia, Bulgaria, Canada, Chile, Colombia, Costa Rica, Dominican Republic, Ecuador, Egypt, France, Germany, Hong Kong, Hungary, Iran, Israel, Italy, Japan, Lebanon, Lithuania, Malaysia, Mexico, Morocco, Netherlands, Pakistan, Panama, Poland, Romania, Russia, Saudi Arabia, Serbia, Spain, Taiwan, Thailand, Tunisia, Turkey, and the UAE. Affected lot numbers include 62699693, 62735177, 62712431, 62743168, 62766610, 62702589, 62710484, 62712437, 62743075, 62750487, 62753787, 62756920, 62759862, 62760388, 62768456, 62773158, and 62728173. Healthcare providers should stop using the affected drivers and contact Zimmer Dental Inc for further instructions.

The recalled product

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 t
Manufacturer
Zimmer Dental Inc
Category
Medical Device — Dental Implant Instrument
Hazard
Affected units
627

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (14)

  • 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.

Distribution

Distribution scope not specified by the agency.

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