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U.S. Department of Health and Human Services

Class 2 Device Recall Tapered ScrewVent Implant System

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  Class 2 Device Recall Tapered ScrewVent Implant System see related information
Date Initiated by Firm May 10, 2018
Create Date August 31, 2018
Recall Status1 Terminated 3 on August 19, 2020
Recall Number Z-2963-2018
Recall Event ID 80609
510(K)Number K111889  
Product Classification Implant, endosseous, root-form - Product Code DZE
Product Outer Package Label: Tapered Screw-Vent Implant System, 4.1mm X 10mm, 3.5mm, REF:TSVM4B10, Sterile:R, Rx Only; Inner Package Label: Implant, MTX, 3.7mm x 10mm,3.5mm, REF: TSVB10.

Zimmer Dental Implants are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.
Code Information Outer Package Label: LOT: 63781164, UDI: (01) 00889024019621 (10) 63781164 (17) 220930 (10) 63781164; Inner Package Label: LOT: 63773888, UDI: (01) 00889024019508 (17) 220930 (10)63773888.
Recalling Firm/
Manufacturer		 Zimmer Dental Inc
1900 Aston Ave
Carlsbad CA 92008-7308
For Additional Information Contact
561-776-6988
Manufacturer Reason
for Recall		 Dental implants have incorrect item/lot numbers and size on the inner package labeling. Correct item/lot numbers and size are on the outer package labeling.
FDA Determined
Cause 2		 Labeling mix-ups
Action The firm, Zimmer Biomet, sent an "Medical Device Recall" notice dated 5/10/2018 via FedEx/UPS courier to its customers. OUS distributors received a "distributor" notice. The notice described the product, problem and actions to be taken. The Customers were instructed to immediately return affected product to Field Action, PM Regulatory Compliance, Zimmer Biomet, 4555 Riverside Dr., Palm Beach Gardens, FL 33410 US and asked to complete and return a Certificate of Acknowledgement. and send to CorporateQuality.PostMarket@zimmerbiomet.com. If you have further questions or concerns, please call the Recall Department at 561-776-6700 between 8:00 am and 5:00 pm 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 Commerce 299 units
Distribution Worldwide Distribution: US (nationwide) in states of: AL, CA, CO, CT, FL, GA, ID, IL, MA, MD, MI, MN, MO, NH, NJ, NY, PA,TN, TX, UT, VA, and WA; and to countries of: Australia, Bulgaria, Canada, Croatia, France, Germany, Italy, Portugal, and 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.
510(K) Database 510(K)s with Product Code = DZE and Original Applicant = ZIMMER DENTAL INC.
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