| Class 2 Device Recall Spectra System Dental Implants |  |
Date Initiated by Firm | October 11, 2019 |
Date Posted | February 05, 2020 |
Recall Status1 |
Terminated 3 on April 12, 2024 |
Recall Number | Z-1157-2020 |
Recall Event ID |
84777 |
510(K)Number | K090234 |
Product Classification |
Implant, endosseous, root-form - Product Code DZE
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Product | Implant Direct, CE 0086, REF: 855710, Legacy 3 Impant, Surface: SBM, Qty:1, Size:5.7mmD x 10mmL, 5.7mmD Platform, RxOnly, Sterile R, |
Code Information |
Lot # 68209 |
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 | Through a customer complaint and and internal investigation it was determined that some implant packages contain the incorrect cover screw and extender. This could result in delay in surgery and/or a potential new surgical procedures to place the correct parts. The level of severity varies based on a one or two stage surgery. |
FDA Determined Cause 2 | Mixed-up of materials/components |
Action | On October 11, 2019 the firm sent an "URGENT: MEDICAL DEVICE RECALL" letter via FedEx overnight priority mail. The letter advised the consignees of the recall. In addition, the letter states:
We request that you take the following actions immediately:.
1. Please review your inventory for the affected product. If located, please quarantine the affected product and return the product to us according to the instructions on the attached form.
2. Please complete and return the Acknowledgement Form within fortyeight (48) hours of receipt of this notification, whether you have affected product or not.
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 questions 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. If you or your patients have experienced any issues as a result of the affected products noted in this URGENT: MEDICAL DEVICE RECALL HHE 855710 100419 Rev 01 Status: RELEASED printed 10/10/2019 2:27:23 PM by Jose Trejo
www.implantdirect.com | 888-649-6425
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 | 78 implants |
Distribution | US: AR, AZ, CA, ID, IL, IN, KY, MD, ND, NH, NJ, NV, NY, Oh, OR, PA, TX, UT, WA, WI, WV, GA,MO |
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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