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U.S. Department of Health and Human Services

Class 2 Device Recall Zimmer Dental GemLock RHD2.5 Hex Driver

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 Class 2 Device Recall Zimmer Dental GemLock RHD2.5 Hex Driversee related information
Date Initiated by FirmOctober 11, 2017
Create DateDecember 21, 2017
Recall Status1 Terminated 3 on March 13, 2019
Recall NumberZ-0279-2018
Recall Event ID 78321
Product Classification Accessories, implant, dental, endosseous - Product Code NDP
ProductZimmer Dental GemLock RHD2.5 Hex Driver. The label shows the product is Manufactured by Zimmer Dental Inc., Carlsbad, CA. Endosseous dental implant accessories are manually powered devices intended to aid in the placement or removal of endosseous dental implants and abutments, prepare the site for placement of endosseous dental implants or abutments, aid in the fitting of endosseous dental implants or abutments, aid in the fabrication of dental prosthetics, and be used as an accessory with endosseous dental implants when tissue contact will last less than 1 hour.
Code Information Lot numbers 63563072, 63572755, 63583270, and 63755802 
Recalling Firm/
Manufacturer		 Zimmer Dental Inc
1900 Aston Ave
Carlsbad CA 92008-7308
For Additional Information ContactZimmer Dental Customer Service
561-776-6988
Manufacturer Reason
for Recall		The device may contain a manufacturing condition affecting the geometry of the driver's hex feature which prevents it from properly engaging the fixture mount transfer and/or a dental implant.
FDA Determined
Cause 2		Employee error
ActionThe recalling firm, Zimmer Biomet, issued "URGENT MEDICAL DEVICE RECALL" letters addressed to Clinicians dated 10/11/2017 via FedEx on 10/11/2017. Letters to the distributors dated 10/11/2017 were issued via courier or email on 10/11/2017. The letters described the product, problem and actions to be taken. The customers were instructed to review notification for awareness; review your inventory; immediately return all affected product from your facility to: Field Action PM Regulatory Compliance Zimmer Biomet 4555 Riverside Dr. Palm Beach Gardens, FL 33410 US and complete and return the Certificate of Acknowledgment by fax to 574-372-4265 or email: CorporateQuality.Postmarket@zimmberbiomet.com. If you have further questions or concerns after reviewing this notice, please call the Recall Department at 561-776-6700 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a prompt to leave a voicemail. Alternatively, your questions may be emailed to CorporateQuality.PostMarket@zimmerbiomet.com.
Quantity in Commerce356 units
DistributionWorldwide Distribution: US (nationwide) and countries of: Canada, Australia, Belgium, Bulgaria, Chile, Costa Rica, Egypt, France, Georgia, Germany, Hong Kong, Hungary, Iran, Ireland, Israel, Italy, Japan, Lebanon, Lithuania, Netherlands, Nicaragua, Poland, Portugal, Romania, Serbia, Shanghai, Spain, Taiwan, Thailand, Tunisia, Turkey, UK, and United Arab Emirates.
Total Product Life CycleTPLC 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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