Zimmer Dental Inc: Medical Device Recall in 2015 - (Recall #: Z-1115-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: January 22, 2015

Date Posted: February 18, 2015

Recall Number: Z-1115-2015

Event ID: 70304

Reason for Recall:

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

Status: Terminated

Product Quantity: 627 units

Code Information:

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 Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated