Recall Z-1115-2015 ยท NDP Accessories, Implant, Dental, Endosseous
Zimmer Dental Inc
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.
| Date | Feb 12, 2015 (initiated Jan 22, 2015) |
| Status | Terminated |
| Reason | The Gemlock Long Hex Driver may not fit into the Fixture Mount Transfer (FMT) or the internal hex of the implant. |
| Root cause | Device Design |
| Action | An Urgent Device Recall Notice was sent on 1/22/15 to their domestic and foreign customers who purchased the Gemlock Long Hex Driver. The letter informs the customers of the problems identified, risks, and the actions to be taken. Customers are instructed to review the notice and check their inventory for the affected units. All affected product is to be immediately quarantined and removed from service. Customers are to contact Simmer Dental Customer Service at 1-800-854-7019 to obtain a Return Authorization Number and set up return of the products. Customers should complete the attached |
| Quantity | 627 units |
| Distribution | 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, Russi |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.