CLASS II Device recall · Reported 18 Feb 2015 · FDA Enforcement Report

GemLock Long Hex Driver recalled by Zimmer Dental

Zimmer Dental is recalling GemLock Long Hex Driver. The recall was initiated on 22 Jan 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesEtched 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.

Quantity recalled627 units

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-1115-2015
FDA event ID: 70304
Recalling firm: Zimmer Dental, Carlsbad, CA
Classification: Class II
Status: Terminated
Recall initiated: 22 Jan 2015
FDA classified: 12 Feb 2015
Reported: 18 Feb 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Surgical Instruments

Timeline

22 Jan 2015	Recall initiated by company
12 Feb 2015	Classified by FDA	+21 days
18 Feb 2015	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 Gemlock Long Hex Driver may not fit into the Fixture Mount Transfer (FMT) or the internal hex of the implant.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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.

Where it was distributed

Worldwide Distribution -- 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, Taiwan, Thailand, Tunisia, Turkey, and UAE. Expanded Distribution: Spain

Questions about this recall

Why was it recalled?

The Gemlock Long Hex Driver may not fit into the Fixture Mount Transfer (FMT) or the internal hex of the implant.

Which lots are affected?

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.

Where was it sold?

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.

More recalls from Zimmer Dental

All 33

Reported	Class	Recall	Company	Reason	Where
12 Sep 2018Device	CLASS II	Outer Package Label: Tapered Screw-Vent Implant System recalled	Zimmer Dental	Packaging Defects	Nationwide
4 Apr 2018Device	CLASS II	Tapered Screw-Vent MTX, Dental Implant, sterile recalled	Zimmer Dental	Labeling Errors	Nationwide
4 Apr 2018Device	CLASS II	Tapered Screw-Vent MTX, Dental Implant, sterile recalled	Zimmer Dental	Labeling Errors	Nationwide
27 Dec 2017Device	CLASS II	Instrument Kit System, Tapered Screw-Vent Implant System recalled	Zimmer Dental	Other	Nationwide
27 Dec 2017Device	CLASS II	Instrument Kit System, Tapered Screw-Vent Implant System recalled	Zimmer Dental	Other	Nationwide

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