RecallDepth

Legacy 3 Implant, Size: 4.2mmD x 13mmL, 3.5mmD Platform, REF: 864213

Company
Implant Direct Sybron Manufacturing, Llc
Recall Initiated
October 7, 2019
Posted
February 4, 2020
Terminated
April 28, 2021
Recall Number
Z-1041-2020
Quantity
72
Firm Location
Westlake Village, CA

Reason for Recall

Some dental implant packages contain incorrect implants, which could lead to surgery rescheduling.

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

Lot / Code Info

Lot: 83327

Root Cause

Packaging process control

Action Taken

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.

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