FDA Device Recall Z-0018-2020: Implant Direct Sybron Manufacturing, LLC

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0018-2020.

Recall Res Number

Z-0018-2020

Recalling Firm / Manufacturer

Implant Direct Sybron Manufacturing, LLC

FEI Number

3001617766

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2018-08-08

Date Posted

N/A

Date Terminated

2019-10-07

Product Code

DZE

Event Number

83518

Product Quantity

22 vials

Product Description ImplantDirect Legacy 3 Implant, REF 855216, SBM implant assembly, 2mmD x 16mmL, 4.5mmD platform, Rx, Sterile. The mislabeled model/part number on the vial cap is 835216. The responsible firm on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA. - Product Usage:Implant Direct Sybron Manufacturing LLC s dental implant product line consists of one-piece and two-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.

Reason for Recall Two units in distribution were found to be mislabeled on the vial cap with the incorrect part number.

Action Details Recall letters dated 8/8/2018 were issued on 8/8/2018 via FedEx overnight mail to the U.S. and Canadian consignees and via email to the UAE consignee.

Distribution Pattern Worldwide distribution - US Nationwide including the states of CO, HI, ID, KS, NC, OH, OR, PA, SC, TN, and UT, and countries of Canada and the United Arab Emirates.

Code Information / Serial Numbers Lot number 110350

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Medical Device Recall: Z-0018-2020

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer