GemLock Long Hex Driver recall
GemLock Long Hex Driver, Catalog RHL2.5; Also distributed within the Tapered SwissPlus & SwissPlus Implant Systems Kits, Surgical, Complete, Catalog…
Why was GemLock Long Hex Driver recalled?
The Gemlock Long Hex Driver may not fit into the Fixture Mount Transfer (FMT) or the internal hex of the implant.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- Product
- GemLock Long Hex Driver, Catalog RHL2.5; Also distributed within the Tapered SwissPlus & SwissPlus Implant Systems Kits, Surgical, Complete, Catalog…
- Recalling firm
- Zimmer Dental Inc
- 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, Russia, Saudi Arabia, Serbia, Taiwan, Thailand, Tunisia, Turkey, and UAE. Expanded Distribution: Spain
- Recall date
- February 18, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)