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U.S. Department of Health and Human Services

Class 2 Device Recall Implant Direct Legacy Implant

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 Class 2 Device Recall Implant Direct Legacy Implantsee related information
Date Initiated by FirmMay 29, 2018
Create DateOctober 09, 2018
Recall Status1 Terminated 3 on July 29, 2020
Recall NumberZ-0089-2019
Recall Event ID 80297
Product Classification Accessories, implant, dental, endosseous - Product Code NDP
ProductImplant Direct Legacy Implant Closed-Tray Transfer-Concave Profile, 3.5mmD Platform. Dental implant component, used temporarily during impressions for the prosthetic procedure.
Code Information Part number 8735-05, Lot number 90212
FEI Number 3001617766
Recalling Firm/
Manufacturer		 Implant Direct Sybron Manufacturing, LLC
3050 E Hillcrest Dr
Thousand Oaks CA 91362
For Additional Information ContactElizabeth Dunn
818-649-6425 Ext. 5467
Manufacturer Reason
for Recall		Cap may be mislabeled with incorrect part number, although the correct part number is on the main vial label.
FDA Determined
Cause 2		Process control
ActionOn May 29, 2018, Implant Direct Sybron Manufacturing LLC issued URGENT MEDICAL DEVICE RECALL notices to their customers via FedEx overnight mail. Customers were instruction to take the following actions: 1. Review your inventory for the affected product. 2. Complete and return the Acknowledgement Form within 48 hours for the product listed; Quarantine and return impacted product. 3. Authorized Implant Direct Sybron Manufacturing LLC distributors, should identify those customers that may have been shipped the affected product lot and contact these customers to inform them of this issue within48 hours of receipt of the notification. Customers with questions may contact Implant Direct Sybron Manufacturing LLC Customer Care at 888-649-6425. Customer Care is available Monday through Friday, between the hours of 5am-5pm PST.
Quantity in Commerce217 units
DistributionWorldwide distribution. US nationwide, Canada, Germany, Great Britain, Kuwait, Lithuania, Monaco, Netherlands, and Slovakia.
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.
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