FDA-Device2018-05-30Class II
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.
Implant Direct Sybron Manufacturing, LLC
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.
Sold states
Distribution was made to FL, GA, MD, MI, NC, NY, OR, TX, UT and VA. There was no foreign/military/government distribution.
Affected count
18 units
Manufactured in
3050 E Hillcrest Dr, N/A, Westlake Village, CA, United States
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1920-2018Don't want to check this manually?
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