Z-0018-2020 Class II Terminated
FDA device recall Z-0018-2020 was initiated by Implant Direct Sybron Manufacturing, LLC on August 8, 2018 and is designated Class II. Reason for recall: Two units in distribution were found to be mislabeled on the vial cap with the incorrect part number. The recall status is terminated (terminated October 7, 2019). Affected quantity: 22 vials.
Recall Details
- Product Type
- Devices
- Report Date
- October 9, 2019
- Initiation Date
- August 8, 2018
- Termination Date
- October 7, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- 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.
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
Lot number 110350