Reported Feb 18, 2015 · Terminated
GemLock Long Hex Driver, Catalog RHL2.5; Also distributed within the Tapered SwissPlus & SwissPlus Implant Systems…
Zimmer Dental Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Zimmer Dental Inc · 1900 Aston Ave · Carlsbad, CA · 92008-7308
Is this the product you have?
- 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.
- Lot codes and dates
- Etched Lot No. 62699693 & 62735177
- Lot Number on Label
62712431627431686276661062702589627104846271243762743075627504876275378762756920627598626276038862768456and 62773158. Expanded Lot No. 62728173
- Amount recalled
- 627 units
Why it was recalled
The Gemlock Long Hex Driver may not fit into the Fixture Mount Transfer (FMT) or the internal hex of the implant.
This product could cause temporary or reversible health problems — stop using it.
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