Micro Surgery Handpiece SGA, Model SGA-ES, Order Code:H263, Manufactured by: 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.

Class I - Dangerous

🏥 Medical Devices Recalled: June 1, 2018 Nakanishi Implants & Prosthetics

What Should You Do?

Check if you have this product:
Previous Operation Manuals: OM-SH0015E002, OM-SH0015E003, OM-SH0015E004, OM-SH0015E005, OM-SH0100F, OM-SH0096S. Model Name: SGA-ES Order Code: H263 0BB10068 - 0BB10069; 0BB20006 -0BB20010; 0BB30044-0BB30046, 0BB30051 - 0BB30053; 0BB60035 - 0BB60042; 0BB70021, 0BB70022, 0BB70025, 0BB70026, 0BB60063 - 0BB60072; 0BB70020, 0BB70023, 0BB70024,0BBX0042 - 0BBX0044; 0BC10046 - 0BC10070; 0BC20053 - 0BC20060; 0BC30011 - 0BC30014, 0BC30081 -0BC30087; 0BC40041- 0BC40043; 0BC40054 -0BC40063; 0BC50009- 0BC50018; 0BC50041-0BC50044, 0BC50046- 0BC50055, 0BC50065, 0BC50066, 0BC50073, 0BC50074, 0BC60010- 0BC60019; 0BC90031 - 0BC90035; 0BCY0086 - 0BCY0095; 0BD50003 -0BD50012; ABDZ0011 -ABDZ0020; ABDZ0083-ABDZ0102, ABDZ0112-ABDZ0117; ABE30001-ABE30015 , ABE30017- ABE30034; ABE40069 - ABE40088, ABE40095, ABE40096, ABE50001- ABE50010, ABE50012- ABE50021; ABE40090; ABE50036 - ABE50040; ABE90009 - ABE90018; ABE90041 - ABE90050; ABEY0001- ABEY0010; ABF40022 - ABF40041; ABF50031- ABF50040; ABF70020 - ABF70025; ABF70058 - ABF70065; ABFY0021- ABFY0030, ABFX0030, ABFY0001 - ABFY0006, ABFY0008-ABFY0010; ABFZ0034- ABFZ0039, ABFZ0041, ABFZ0042, ABFZ0044- ABFZ0053;ABG40011-ABG40022; ABG40024; ABG70128, ABG70129, ABG70131 - ABG70140; ABG80001-ABG80018; ABG90125 -ABG90127, ABG90129, ABG90130, ABG90132, ABG90133; ABH30023.
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: Nakanishi Inc.
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.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: terminated

Product Information

Full Description:

Micro Surgery Handpiece SGA, Model SGA-ES, Order Code:H263, Manufactured by: 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.

Product Codes/Lot Numbers:

Previous Operation Manuals: OM-SH0015E002, OM-SH0015E003, OM-SH0015E004, OM-SH0015E005, OM-SH0100F, OM-SH0096S. Model Name: SGA-ES Order Code: H263 0BB10068 - 0BB10069; 0BB20006 -0BB20010; 0BB30044-0BB30046, 0BB30051 - 0BB30053; 0BB60035 - 0BB60042; 0BB70021, 0BB70022, 0BB70025, 0BB70026, 0BB60063 - 0BB60072; 0BB70020, 0BB70023, 0BB70024,0BBX0042 - 0BBX0044; 0BC10046 - 0BC10070; 0BC20053 - 0BC20060; 0BC30011 - 0BC30014, 0BC30081 -0BC30087; 0BC40041- 0BC40043; 0BC40054 -0BC40063; 0BC50009- 0BC50018; 0BC50041-0BC50044, 0BC50046- 0BC50055, 0BC50065, 0BC50066, 0BC50073, 0BC50074, 0BC60010- 0BC60019; 0BC90031 - 0BC90035; 0BCY0086 - 0BCY0095; 0BD50003 -0BD50012; ABDZ0011 -ABDZ0020; ABDZ0083-ABDZ0102, ABDZ0112-ABDZ0117; ABE30001-ABE30015 , ABE30017- ABE30034; ABE40069 - ABE40088, ABE40095, ABE40096, ABE50001- ABE50010, ABE50012- ABE50021; ABE40090; ABE50036 - ABE50040; ABE90009 - ABE90018; ABE90041 - ABE90050; ABEY0001- ABEY0010; ABF40022 - ABF40041; ABF50031- ABF50040; ABF70020 - ABF70025; ABF70058 - ABF70065; ABFY0021- ABFY0030, ABFX0030, ABFY0001 - ABFY0006, ABFY0008-ABFY0010; ABFZ0034- ABFZ0039, ABFZ0041, ABFZ0042, ABFZ0044- ABFZ0053;ABG40011-ABG40022; ABG40024; ABG70128, ABG70129, ABG70131 - ABG70140; ABG80001-ABG80018; ABG90125 -ABG90127, ABG90129, ABG90130, ABG90132, ABG90133; ABH30023.

Distribution:

Distributed in: CA, FL, GA, IL, WA

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0225-2019

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