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U.S. Department of Health and Human Services

Class 2 Device Recall Simply InterActive Implant

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 Class 2 Device Recall Simply InterActive Implantsee related information
Date Initiated by FirmOctober 26, 2018
Create DateNovember 12, 2019
Recall Status1 Terminated 3
Recall NumberZ-0363-2020
Recall Event ID 83794
510(K)NumberK130572 
Product Classification Implant, endosseous, root-form - Product Code DZE
ProductImplant Direct, REF654311U, simply InterActive Implant, Surface: SBM, Qty 1, 4.3mmD x 11.5mmL, 3.4mmD Platform, RX only, Sterile R Dental Implant
Code Information Lot numbers 120197; Exp. 07/16/2023 and 120198; Exp. 07/19/2023
Recalling Firm/
Manufacturer
Implant Direct Sybron Manufacturing, LLC
3050 E Hillcrest Dr
Westlake Village CA 91362-3171
For Additional Information ContactElizabeth Dunn
888-649-6425 Ext. 5467
Manufacturer Reason
for Recall
packaging error; An internal QA inspection revealed that a incorrect healing collar could have been packaged in an implant assembly kit.
FDA Determined
Cause 2
Packaging
ActionOn 10/25/2018, a "URGENT: MEDICAL DEVICE RECALL" letter was sent to consignees via FedEx Priority overnight. The notification stated the following: 1. Please review your inventory for the affected product. 2. Please complete and return the Acknowledgement Form within 48 hours for the product listed above; Quarantine product and return product listed above. 3. If you are an authorized Implant Direct Sybron Manufacturing LLC distributor, we request 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 of receipt of this notification. 4.If you have any of the affected product listed above, please return the product and we will send you a replacement part. 5.If you have any questions contact Implant Direct Sybron LLC Customer Care at 888-649-6425. Customer Care is available Monday through Friday, between the hours of 5am-5pm PST. 6. If you or your patients have experienced any issues as a result of the affected products noted in this communication, you may voluntarily report the incident to the FDA through the MEDWATCH reporting system at the following: http://www.fda.gov/Safety/MedWatch/HowToReport/ucm053074.htm
Quantity in Commerce53 implants
DistributionUS distribution in the states of: CA, UT, VA, NY, IL, AR, TX, OH, NV, FL, ID, AK, NC, KS, MN, AZ, CO,
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.
510(K) Database510(K)s with Product Code = DZE
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