| Class 2 Device Recall Simply InterActive Implant |  |
Date Initiated by Firm | October 26, 2018 |
Create Date | November 12, 2019 |
Recall Status1 |
Terminated 3 |
Recall Number | Z-0363-2020 |
Recall Event ID |
83794 |
510(K)Number | K130572 |
Product Classification |
Implant, endosseous, root-form - Product Code DZE
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Product | Implant 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
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For Additional Information Contact | Elizabeth 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 |
Action | On 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 Commerce | 53 implants |
Distribution | US 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 Cycle | TPLC Device Report |
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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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510(K) Database | 510(K)s with Product Code = DZE
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