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U.S. Department of Health and Human Services

Class 2 Device Recall REPLANT 5.0mmD ABUTMENT, Part number 60505260

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  Class 2 Device Recall REPLANT 5.0mmD ABUTMENT, Part number 60505260 see related information
Date Initiated by Firm May 18, 2018
Create Date July 05, 2018
Recall Status1 Terminated 3 on July 13, 2020
Recall Number Z-2376-2018
Recall Event ID 80281
510(K)Number K061319  
Product Classification Implant, endosseous, root-form - Product Code DZE
Product REPLANT 5.0mmD ABUTMENT, Part number 6050-52-60
Code Information Lot numbers: 45353, 66011, and 75850
Recalling Firm/
Manufacturer		 Implant Direct Sybron Manufacturing, LLC
3050 E Hillcrest Dr
Thousand Oaks CA 91362
For Additional Information Contact Elizabeth Dunn
818-444-3300 Ext. 3323
Manufacturer Reason
for Recall		 Due to out of specification, the clinician would not be able to fit and engage the abutment with the implant
FDA Determined
Cause 2		 Process control
Action On May 18, 2018, Implant Direct Sybron Manufacturing LLC issued URGENT MEDICAL DEVICE RECALL notices to their customers. Customers were advised to take the following action: 1. Inspect your inventory for the affected product. 2. Complete and return the Acknowledgement and Recall Return Form within 48 hours for Quarantine product and return products listed. 3. Please return the product and the firm will send you a replacement part. 4. Authorized Implant Direct Sybron Manufacturing distributors, the firm requests that you identify those customers that may have been shipped the affected product lot and contact these customers to inform them of this issue within fortyeight (48) hours. Customers with questions with questions may contact Implant Direct Sybron Manufacturing LLC Customer Care at 1-888-649-6425. Customer Care is available Monday through Friday, between the hours of 5am-5pm PST.
Quantity in Commerce 60 units
Distribution CA, FL, GA, IL, LA, MI, MT, NC, NJ, NY, OK, OR, SC, SD, TN & WA; International: Jordan, Great Britain, Germany, Spain, Italy & Poland
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 = IMPLANT DIRECT LLC
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