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U.S. Department of Health and Human Services

Class 2 Device Recall Gemlock

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  Class 2 Device Recall Gemlock see related information
Date Initiated by Firm January 22, 2015
Date Posted February 12, 2015
Recall Status1 Terminated 3 on August 03, 2015
Recall Number Z-1115-2015
Recall Event ID 70304
Product Classification Accessories, implant, dental, endosseous - Product Code NDP
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.
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.
Recalling Firm/
Manufacturer		 Zimmer Dental Inc
1900 Aston Ave
Carlsbad CA 92008-7308
For Additional Information Contact
760-929-4107
Manufacturer Reason
for Recall		 The Gemlock Long Hex Driver may not fit into the Fixture Mount Transfer (FMT) or the internal hex of the implant.
FDA Determined
Cause 2		 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 Business Reply Form and fax it to (574) 372-4265 or e-mail to corporatequality.postmarket@zimmer.com. Customers with questions are instructed to contact Zimmer Dental Customer Service at (800) 854-7019, Mon-Fri, 7 am-5pm (Pacific). Zimmer Dental is expanding the recall to include 1 additional lot for catalog no.TSVKIT. Zimmer Dental plans to inform an amended customer notification letter to their US and foreign consignees. The letter will go out to customers on 4/20/15 to inform them of the expanded lot.
Quantity in Commerce 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, Russia, Saudi Arabia, Serbia, Taiwan, Thailand, Tunisia, Turkey, and UAE. Expanded Distribution: Spain
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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