FDANovember 15, 2016device
ImplantDirect Legacy 4 Implant, 5.7mmD x 5.7mmD Platform, Part 885708, Rx, Sterile. The incorrect cap label shows part 855708, 5.7mmD Platform, 8mmL.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The vial cap was mislabeled with the incorrect part number of 855708 but the product description on the cap was correct. The main vial label was correctly labeled.
What to do
FDA enforcement status: Terminated
Brands named
implant direct sybron manufacturingimplantimplant direct
Recall history
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