Legacy 3 Implant, Size: 4.2mmD x 13mmL, 3.5mmD Platform, REF: 864213
FDA Recall Z-1041-2020 · Posted 2020-02-04
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Recalling FirmImplant Direct Sybron Manufacturing LLC
Recall StatusTerminated
Product CodeDZE
Date Initiated2019-10-07
Date Terminated2021-04-28
Product Quantity72
Reason for Recall
Some dental implant packages contain incorrect implants, which could lead to surgery rescheduling.
Firm 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.
Root Cause
Packaging process control
Distribution Pattern
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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