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Recall Observatory FDA recall evidence

Device product

Legacy 3 Implant, Size: 4.2mmD x 13mmL, 3.5mmD Platform, REF: 864213

Z-1041-2020

October 07, 2019

Class II

Product summary

Firm
Implant Direct Sybron Manufacturing LLC
Event
Event 84801
Status
Terminated
Classification
Class II
Quantity
72
Official record key
device-enforcement:Z-1041-2020

Official wording

Reason: Some dental implant packages contain incorrect implants, which could lead to surgery rescheduling.

Code information: Lot: 83327

Distribution pattern: U.S. Nationwide distribution in the states of: KS, LA, OH, RI, CA, NJ, MA, FL, UT, ID, MO, WY, WI, PA, WA. O.U.S. (Foreign): DE, IT, HU, JP

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Some dental implant packages contain incorrect implants, which could lead to surgery rescheduling.