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Recall Observatory FDA recall evidence

Device product

DRW-0739-02: Gen 2 Posterior Chairside Splint LRUL (lower right-upper left) - Product Usage: intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery.

Z-2638-2020

May 14, 2020

Class II

Product summary

Firm
Neocis Inc.
Event
Event 85856
Status
Terminated
Classification
Class II
Quantity
70 units
Official record key
device-enforcement:Z-2638-2020

Official wording

Reason: The LRUL and LLUR posterior chairside splints and LLUR anterior chairside splints may be mislabeled.

Code information: Work Order (lot): 1616, 1621, and 1622

Distribution pattern: US Nationwide distribution including in the states of AZ, CA, FL, NY, and NH

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    mislabeled