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Recall Observatory FDA recall evidence

Device product

Implant Direct, CE 0086, REF: 855710, Legacy 3 Impant, Surface: SBM, Qty:1, Size:5.7mmD x 10mmL, 5.7mmD Platform, RxOnly, Sterile R,

Z-1157-2020

October 11, 2019

Class II

Product summary

Firm
Implant Direct Sybron Manufacturing LLC
Event
Event 84777
Status
Terminated
Classification
Class II
Quantity
78 implants
Official record key
device-enforcement:Z-1157-2020

Official wording

Reason: Through a customer complaint and and internal investigation it was determined that some implant packages contain the incorrect cover screw and extender. This could result in delay in surgery and/or a potential new surgical procedures to place the correct parts. The level of severity varies based on a one or two stage surgery.

Code information: Lot # 68209

Distribution pattern: US: AR, AZ, CA, ID, IL, IN, KY, MD, ND, NH, NJ, NV, NY, Oh, OR, PA, TX, UT, WA, WI, WV, GA,MO

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Through a customer complaint and and internal investigation it was determined that some implant packages contain the incorrect cover screw and extender. This could result in delay in surgery and/or a potential new surgical procedures to place the correct parts. The level of severity varies based on a one or two stage surgery.