Home / Recalls / Nakanishi Inc. / Z-0219-2019

Z-0219-2019 Class II Terminated

Recalled by Nakanishi Inc. — Kanuma, N/A

Recall Details

Product Type
Devices
Report Date
October 31, 2018
Initiation Date
June 1, 2018
Termination Date
April 28, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
12

Product Description

Surgical Handpiece, Model: SGS-E, Order Code: H084, 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.

Reason for Recall

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.

Distribution Pattern

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

Code Information

Previous Operation Manual: OM-H0035E001 Model Name: SGS-E Order Code: H084, Serial Nos. FL400001 - FL400005; FL500008 - FL500010; FL400012-FL400015.

Other recalls by Nakanishi Inc.

  • Z-0222-2019 Class II — Surgical Handpiece, Model: SGA-E2G Order Code: H184, Nakanishi Inc. The SG (June 1, 2018)
  • Z-0221-2019 Class II — Surgical Handpiece, Model: SGA-E Order Code: H083, Nakanishi Inc. The SGS/ (June 1, 2018)
  • Z-0225-2019 Class II — Micro Surgery Handpiece SGA, Model SGA-ES, Order Code:H263, Manufactured by: Na (June 1, 2018)
  • Z-0223-2019 Class II — Micro Surgery Handpiece SGS, Model: SGS-ES, Order Code: H264, Manufactured by: N (June 1, 2018)
  • Z-0226-2019 Class II — Micro Surgery Handpiece SGA, Model SGA-E2S Order Code: H265, Manufactured by: (June 1, 2018)
  • Z-0220-2019 Class II — Surgical Handpiece, Model: SGS-E2G Order Code: H185, Nakanishi Inc. The SGS/ (June 1, 2018)
  • Z-0224-2019 Class II — Micro Surgery Handpiece SGS, Model: SGS-E2S, Order Code: H266, Manufactured by: (June 1, 2018)
  • Z-2674-2016 Class II — Diamond Coated Tips and Burs are accessories to the air powered dental handpiece (July 8, 2016)
  • Z-2672-2016 Class II — Diamond Coated Tips and Burs are accessories to the Ultrasonic Scaler (VARIOS 35 (July 8, 2016)
  • Z-2673-2016 Class II — Diamond Coated Tips and Burs are accessories to the air powered Bone drill (VARI (July 8, 2016)