Recall Z-1115-2015— Zimmer Dental Inc
Class II · Terminated
Class II FDA medical device recall by Zimmer Dental Inc, initiated 2015-01-22, terminated 2015-08-03. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Zimmer Dental Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-01-22
- Terminated
- 2015-08-03
- Firm location
- Carlsbad, CA, United States
Product description
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 for recall
The Gemlock Long Hex Driver may not fit into the Fixture Mount Transfer (FMT) or the internal hex of the implant.
Data sourced from openFDA. This site is unofficial and independent of the FDA.