🔍 RecallPedia

Micro Surgery Handpiece SGA, Model SGA-E2S Order Code: H265, 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?

  1. Check if you have this product:
    Previous Operation Manuals: OM-SH0015E002, OM-SH0015E003, OM-SH0015E004, OM-SH0015E005, OM-SH0100F, OM-SH0096S. Model name: SGA-E2S Order Code: H265 ABB10001-ABB10028, ABB10031-ABB10078, ABB20002, ABB20016, ABB20023- ABB20044, ABB30001- ABB30015, ABB30021-ABB30053, ABB40001-ABB40012, ABB40023-ABB40025, ABB50001-ABB50022, ABB50029-ABB50049; ABB60001, ABB60041-ABB60050, ABB60052-ABB60054, ALZ00064-ALZ00073;ABB10028, ABB10031-ABB10078, ABB20002, ABB20016, ABB20023-ABB20044;ABB30001-ABB30015,ABB30021-ABB30053;ABB40001-ABB40012, ABB40023-ABB40025;ABB50001-ABB50022, ABB50029-ABB50049; ABB60001, ABB60018-ABB60025, ABB60026-ABB60050, ABB60052-ABB60068, ABB60075-ABB60101; ABB90001-ABB90017, ABB90023-ABB90032, ABB90034-ABB90050, ABBX0001-ABBX0008, ABBX0011-ABBX0025, ABBX0032-ABBX0046;ABBZ0009-ABBZ0023;ABBY0012, ABBY0015-ABBY0018, ABBY0041-ABBY0050; ABBZ0029-ABBZ0050; ABC20001-ABC20008, ABC20024-ABC20050;ABC30001-ABC30043, ABC30049-ABC30050; ABC50001-ABC50010; ABC60001-ABC60043, ABC60053-ABC60092, ABC60095-ABC60100;ABC70001-ABC70034, ABC70043-ABC70092; ABC90005-ABC90114, ABC90119-ABC90149;ABCX0001-ABCX0019,ABCX0044-ABCX0100; ABCY0001-ABCY0003; ABCY0032-ABCY0041; ABD20003-ABD20007; ABD10031-ABD10050, ABD10018-ABD10030; ABD50001-ABD50017, ABD50047-ABD50050; ABD90001- ABD90036; BBDZ0001, BBDZ0004, BBDZ0005, BBDZ0033-BBDZ0043, BBE10001-BBE10009,BBE10024-BBE10030, BBE10041-BBE10050, BBE20001-BBE20013;BBE40001-BBE40050; BBE50002-BBE50011, BBE50032-BBE50050;BBE70001,BBE70004-BBE70023-BBE70043, BBE70048-BBE70050;BBE90001-BBE90050;BBEX0001-BBEX0022; BBEX0039-BBEX0058; BBEX0087-BBEX0100; BBF30001-BBF30016;BBF30032-BBF30050; BBF40001, BBF40025-BBF40038; BBF50001-BBF50036, BBF50061, BBF50062, BBF60001-BBF60028;BBFZ0026-BBFZ0065, BBFZ0068-BBFZ0070;BBG10001-BBG10017;BBG30015-BBG30054, BBG30061-BBG30063; BBG60028-BBG60040; BBG70001-BBG70027;BBG80033-BBG80042, BBG80054- BBG80073; BBG80092-BBG80115; BBG90001-BBG90016; BBGX0006-BBGX0035;BBGY0013-BBGY0024;BBGY0054- BBGY0060; BBH10001-BBH10023;BBH10088-BBH10100; BBH20001-BBH20010; BBH20021-BBH20027;BBH30005-BBH30011;BBH40001-BBH40028; BBH50001-BBH50005, BBH50039-BBH50058, BBH50086-BBH50089;BBH60001-BBH60046;BBH70007-BBH70026;BBH70041-BBH70055
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. 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-E2S Order Code: H265, 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-E2S Order Code: H265 ABB10001-ABB10028, ABB10031-ABB10078, ABB20002, ABB20016, ABB20023- ABB20044, ABB30001- ABB30015, ABB30021-ABB30053, ABB40001-ABB40012, ABB40023-ABB40025, ABB50001-ABB50022, ABB50029-ABB50049; ABB60001, ABB60041-ABB60050, ABB60052-ABB60054, ALZ00064-ALZ00073;ABB10028, ABB10031-ABB10078, ABB20002, ABB20016, ABB20023-ABB20044;ABB30001-ABB30015,ABB30021-ABB30053;ABB40001-ABB40012, ABB40023-ABB40025;ABB50001-ABB50022, ABB50029-ABB50049; ABB60001, ABB60018-ABB60025, ABB60026-ABB60050, ABB60052-ABB60068, ABB60075-ABB60101; ABB90001-ABB90017, ABB90023-ABB90032, ABB90034-ABB90050, ABBX0001-ABBX0008, ABBX0011-ABBX0025, ABBX0032-ABBX0046;ABBZ0009-ABBZ0023;ABBY0012, ABBY0015-ABBY0018, ABBY0041-ABBY0050; ABBZ0029-ABBZ0050; ABC20001-ABC20008, ABC20024-ABC20050;ABC30001-ABC30043, ABC30049-ABC30050; ABC50001-ABC50010; ABC60001-ABC60043, ABC60053-ABC60092, ABC60095-ABC60100;ABC70001-ABC70034, ABC70043-ABC70092; ABC90005-ABC90114, ABC90119-ABC90149;ABCX0001-ABCX0019,ABCX0044-ABCX0100; ABCY0001-ABCY0003; ABCY0032-ABCY0041; ABD20003-ABD20007; ABD10031-ABD10050, ABD10018-ABD10030; ABD50001-ABD50017, ABD50047-ABD50050; ABD90001- ABD90036; BBDZ0001, BBDZ0004, BBDZ0005, BBDZ0033-BBDZ0043, BBE10001-BBE10009,BBE10024-BBE10030, BBE10041-BBE10050, BBE20001-BBE20013;BBE40001-BBE40050; BBE50002-BBE50011, BBE50032-BBE50050;BBE70001,BBE70004-BBE70023-BBE70043, BBE70048-BBE70050;BBE90001-BBE90050;BBEX0001-BBEX0022; BBEX0039-BBEX0058; BBEX0087-BBEX0100; BBF30001-BBF30016;BBF30032-BBF30050; BBF40001, BBF40025-BBF40038; BBF50001-BBF50036, BBF50061, BBF50062, BBF60001-BBF60028;BBFZ0026-BBFZ0065, BBFZ0068-BBFZ0070;BBG10001-BBG10017;BBG30015-BBG30054, BBG30061-BBG30063; BBG60028-BBG60040; BBG70001-BBG70027;BBG80033-BBG80042, BBG80054- BBG80073; BBG80092-BBG80115; BBG90001-BBG90016; BBGX0006-BBGX0035;BBGY0013-BBGY0024;BBGY0054- BBGY0060; BBH10001-BBH10023;BBH10088-BBH10100; BBH20001-BBH20010; BBH20021-BBH20027;BBH30005-BBH30011;BBH40001-BBH40028; BBH50001-BBH50005, BBH50039-BBH50058, BBH50086-BBH50089;BBH60001-BBH60046;BBH70007-BBH70026;BBH70041-BBH70055

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-0226-2019

Related Recalls

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.

Nakanishi

Class I - Dangerous

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.

Jun 1, 2018 Implants & Prosthetics View Details →

Surgical Handpiece, Model: SGA-E Order Code: H083, 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.

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Class I - Dangerous

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.

Jun 1, 2018 Implants & Prosthetics View Details →

Micro Surgery Handpiece SGS, Model: SGS-E2S, Order Code: H266, 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..

Nakanishi

Class I - Dangerous

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.

Jun 1, 2018 Implants & Prosthetics View Details →