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Recall Observatory FDA recall evidence

Device product

Surgical Handpiece, Model: SGS-E2G Order Code: H185, Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant use: drilling and tapping the maxilla and mandible.

Z-0220-2019

June 01, 2018

Class II

Product summary

Firm
Nakanishi Inc.
Event
Event 80713
Status
Terminated
Classification
Class II
Quantity
0
Official record key
device-enforcement:Z-0220-2019

Official wording

Reason: Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions of manual cleaning and specific parameters for autoclave sterilization . The previous operation manuals associated with the SGS/SGA products must be replaced by new operation manuals.

Code information: Model Name: SGS-E2G Order Code: H185 *Note: There were no shipments of SGS-E2G between 2011 and April 2018 to the U.S. Market.

Distribution pattern: U.S. Distribution to states of: CA, FL, GA, IL, WA.; and internationally to: Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions of manual cleaning and specific parameters for autoclave sterilization . The previous operation manuals associated with the SGS/SGA products must be replaced by new operation manuals.