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Recall Observatory FDA recall evidence

Device product

Keystone Dental Inc. PrimaConnex Straight Implant TC, WD Internal Connection 5.0 x 11.5mm. Catalog Number(s): 15636K

Z-1818-2017

March 09, 2017

Class II

Product summary

Firm
Keystone Dental Inc
Event
Event 76782
Status
Terminated
Classification
Class II
Quantity
59 units
Official record key
device-enforcement:Z-1818-2017

Official wording

Reason: Straight PrimaConnex Implants contained Tapered PrimaConnex Implants

Code information: Lot Number: 30214

Distribution pattern: CA, IL, IN, FL, MA, MN, NJ, NV, PA,

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Straight PrimaConnex Implants contained Tapered PrimaConnex Implants