Device product
ImplantDirect, REF 834711, Legacy 2 Implant 4.7mmD x 11.5mmL, 4.5mmD Platform,
Z-0197-2022
Product summary
- Event
- Event 88859
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 61 implants
- Official record key
device-enforcement:Z-0197-2022
Official wording
Reason: Packaged dental implant contains a different size then the size declared on the labeling.
Code information: lot # 166297 / UDI: 10841307101789
Distribution pattern: Worldwide distribution - US Nationwide distribution in the states of AZ, CA, HI, IL, KS, LA, MA, MD, MI, MO, MT, NE, NJ, NY, OH, OR, PA, RI, SC, TX, UT, VA, WA, WI and the country of Japan.
Derived failure modes
-
Unknown
Packaged dental implant contains a different size then the size declared on the labeling.