| Class 2 Device Recall Legacy 3 Implant |  |
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
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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
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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 |
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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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