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U.S. Department of Health and Human Services

Class 2 Device Recall Legacy 3 Implant

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  Class 2 Device Recall Legacy 3 Implant see related information
Date Initiated by Firm October 07, 2019
Date Posted February 04, 2020
Recall Status1 Terminated 3 on April 28, 2021
Recall Number Z-1041-2020
Recall Event ID 84801
510(K)Number K090234  
Product Classification Implant, endosseous, root-form - Product Code DZE
Product Legacy 3 Implant, Size: 4.2mmD x 13mmL, 3.5mmD Platform, REF: 864213
Code Information Lot: 83327
Recalling Firm/
Manufacturer		 Implant Direct Sybron Manufacturing LLC
3050 E Hillcrest Dr
Westlake Village CA 91362-3171
For Additional Information Contact Elizabeth Dunn
888-649-6425 Ext. 5467
Manufacturer Reason
for Recall		 Some dental implant packages contain incorrect implants, which could lead to surgery rescheduling.
FDA Determined
Cause 2		 Packaging process control
Action On 10/07/19, Urgent Medical Device Recall notices were mailed via overnight mail to US customers who were asked to return affected product and to complete and return the acknowledgement form. Consignees in foreign countries were sent Recall notices via overnight mail and/or email on 10/11/2019. Distributors were asked to identify customers that may have received affected product and to inform them of this issue. US Customers with additional questions were encouraged to call Customer Care, Monday through Friday, between 5am-5pm PST, at 1-888-649-6425.
Quantity in Commerce 72
Distribution U.S. Nationwide distribution in the states of: KS, LA, OH, RI, CA, NJ, MA, FL, UT, ID, MO, WY, WI, PA, WA. O.U.S. (Foreign): DE, IT, HU, JP
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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