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Recall Observatory FDA recall evidence

Device product

SwishTapered Implant Intended for use in support for fixed bridgework.

Z-1167-2018

January 19, 2018

Class II

Product summary

Firm
Implant Direct Sybron Manufacturing, LLC
Event
Event 79396
Status
Terminated
Classification
Class II
Quantity
1,117 units total
Official record key
device-enforcement:Z-1167-2018

Official wording

Reason: The extender that is packaged with the SwishTapered" and SwishPlus" Implant may have been packaged in the incorrect position (upside down in the plastic retainer).

Code information: Part No. (Lot No.): 934106 (68075, 69252, 79574), 934112 (69101, 80912), 934806 (68076, 75219), 934812 (68078, 68889), 934814 (67980), and 935712 (68077).

Distribution pattern: Worldwide Distribution -- US, Europe, Canada, Australia, and Japan.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The extender that is packaged with the SwishTapered" and SwishPlus" Implant may have been packaged in the incorrect position (upside down in the plastic retainer).