Device product
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.
Z-0018-2020
Product summary
- Event
- Event 83518
- Status
- Terminated
- Classification
- Class II
- Quantity
- 22 vials
- Official record key
device-enforcement:Z-0018-2020
Official wording
Reason: Two units in distribution were found to be mislabeled on the vial cap with the incorrect part number.
Code information: Lot number 110350
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.
Derived failure modes
-
Labeling or packaging
mislabeled