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Implant Direct Sybron Manufacturing, LLC recalls ImplantDirect Legacy 4 Implant, 5.7mmD x 5.7mmD Platform, Part 885708, Rx, Sterile. The incorrect cap label shows part
Recalled May 30, 2018 · FDA recall Z-1920-2018 · Implant Direct Sybron Manufacturing
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. · FDA Class II
Units
18 units
Sold at
Distribution was made to FL, GA, MD, MI, NC, NY, OR, TX, UT and VA. There was no foreign/military/government distribution.
Description
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.
Product
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.
Manufacturer(s)
Implant Direct Sybron Manufacturing, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →