FDA event 80713 · Recall Observatory

device · product 1 of 8

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.

Z-0219-2019

Recall number: Z-0219-2019
Initiated: June 01, 2018
Classification: Class II
Status: Terminated
Recalling firm: Nakanishi Inc.
Quantity: 12

App-derived interpretation

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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

Distribution pattern

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

device · product 2 of 8

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

Recall number: Z-0220-2019
Initiated: June 01, 2018
Classification: Class II
Status: Terminated
Recalling firm: Nakanishi Inc.
Quantity: 0

App-derived interpretation

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

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.

device · product 3 of 8

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.

Z-0221-2019

Recall number: Z-0221-2019
Initiated: June 01, 2018
Classification: Class II
Status: Terminated
Recalling firm: Nakanishi Inc.
Quantity: 18

App-derived interpretation

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Previous Operation Manual: OM-H0035E001 Model Name: SGA-E, Order Code: H083 FL800010-FL800020; FLY00001-FLY00007.

Distribution pattern

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

device · product 4 of 8

Surgical Handpiece, Model: SGA-E2G Order Code: H184, 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-0222-2019

Recall number: Z-0222-2019
Initiated: June 01, 2018
Classification: Class II
Status: Terminated
Recalling firm: Nakanishi Inc.
Quantity: 6

App-derived interpretation

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Previous Operation Manual: OM-H0035E001 Model Name: SGA-E2G Order Code: H184 Serial Nos. BL600026 - BL600031

Distribution pattern

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

device · product 5 of 8

Micro Surgery Handpiece SGS, Model: SGS-ES, Order Code: H264, 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.

Z-0223-2019

Recall number: Z-0223-2019
Initiated: June 01, 2018
Classification: Class II
Status: Terminated
Recalling firm: Nakanishi Inc.
Quantity: 2419

App-derived interpretation

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Previous Operation Manuals: OM-SH0015E002,OM-SH0015E003, OM-SH0015E004, OM-SH0015E005, OM-SH0100F, OM-SH0096S Model Name: SGS-ES; Order Code H264/H264007 Serial Nos.:0LZ00063 - 0LZ00064, 0LZ00066 - 0LZ00068, 0LZ00070 - 0LZ00109; 0LZ00110 - 0LZ00115; 0BB20112 -0BB20116, 0BB20226 - 0BB20229, 0BB40071 - 0BB40075, 0BB50186 - 0BB50189, 0BB50215 - 0BB50224, 0BB50263, 0BB50265, 0BB50266, 0BB50185, 0BB50190 - 0BB50192; 0BB60051 - 0BB60055, 0BB60079 - 0BB60100, 0BB60106 -0BB60118, 0BB70066 - 0BB70100, 0BB90004 - 0BB90058, 0BB90123 - 0BB90132, 0BBX0168 - 0BBX0175;0BBY0188 -0BBY0192; 0BC10095 - 0BC10099, 0BC10101 - 0BC10110, 0BC10121 - 0BC10130, 0BC10169 - 0BC10170, 0BC10176- 0BC10179, 0BC50093 - 0BC50102, 0BC60001 - 0BC60040, 0BC60085 - 0BC60104, 0BC60078 - 0BC60081, 0BC90001 - 0BC90090; 0BCY0003 - 0BCY0032; 0BD40011 -0BD40020, 0BD60001 - 0BD60034, 0BD60008 - 0BD60010, 0BD60016, 0BD60142-0BD60150, 0BD70062-0BD70072, 0BD80001 -0BD80034, 0BD80095 - 0BD80100, 0BDX0021 -0BDX0040, 0BDX0084- 0BDX0093; 0BDY0001- 0BDY0068, ABE10092 - ABE10121, ABE30001 - ABE30068, ABE30079 - ABE30088, ABE 60001- ABE60068, ABE 60056-ABE60065, ABE60005, ABE60011-ABE60015, ABE60030, ABE60136 - ABE60145, ABE70051- ABE70056, ABE90099-ABE90100; ABEX0001- ABEX0008; ABEY0052 - ABEY0071, ABEX0141 - ABEX0149; ABEY0011 - ABEY0020, ABEY0051; ABF10011- ABF10030, ABF20050, ABF20071 - ABF20079, ABF30014 - ABF30033, ABF70161 - ABF70166; ABFX0046 - ABFX0051, ABFX0053, ABFX0063, ABFY0031 -ABFY0033, ABFY0038- ABFY0040, ABFZ0043-ABFZ0062, ABFY0121 - ABFY0130; ABFZ0001 - ABFZ0040;ABG60147- ABG60154, ABG60156, ABG60159 - ABG60166; ABG70011- ABG70018, ABG70039 - ABG70048, ABG70059 -ABG70090; ABH50001 - ABH50009, ABH50010- ABH50400; ABH40106 - ABH40115; ABH60128 - ABH60137; ABH70001 - ABH70505; ABH80329- ABH80338; ABHX0001 - ABHX0343 - ;

Distribution pattern

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

device · product 6 of 8

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..

Z-0224-2019

Recall number: Z-0224-2019
Initiated: June 01, 2018
Classification: Class II
Status: Terminated
Recalling firm: Nakanishi Inc.
Quantity: 1662

App-derived interpretation

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Previous Operation Manuals:OM-SH0015E002, OM-SH0015E003,OM-SH0015E004, OM-SH0015E005, OM-SH0100F,OM-SH0096S. Model Name: SGS-E2S; Order Code H266 Serial Nos.:0LZ00004 -0LZ00013, 0LZ00015- 0LZ00018, 0LZ00021 - 0LZ00030, 0LZ00036 - 0LZ00040, 0LZ00043- 0LZ00054 ; 0BB30001-0BB30010, 0BB30012 - 0BB30015; 0LZ00058; 0BB30022 - 0BB30026; 0BB50001-0BB50013, 0BB50021 - 0BB50025; 0BB70003 - 0BB70015; 0BB90007-0BB90027; 0BBX0001 - 0BBX0010; 0BBY0001 - 0BBY0027, 0BBY0031 - 0BBY0035; 0BBZ0017 - 0BBZ0026, 0BBZ0035 - 0BBZ0050; 0BC30001 - 0BC30004; 0BBZ0002 - 0BBZ0008; 0BC30008 - 0BC30020; 0BC50001 - 0BC50010; 0BC60001- 0BC60004, 0BC60006 - 0BC60031, 0BC60036 - 0BC60050; 0BC70001 - 0BC70015; 0BC90006 - 0BC90025, 0BC90031 - 0BC90050, 0BC90054 -0BC90060 - 0BC90080; 0BCX0001-0BCX0023; 0BCY0003 - 0BCY0027; 0BD10012 - 0BD10020; 0BD30001- 0BD30003, 0BD30006, 0BD30010- 0BD30018, 0BD10021 - 0BD10030; 0BD30028- 0BD30037; 0BD60021 - 0BD60030; 0BD60004 - 0BD60020, 0BD60031 - 0BD60033, 0BD60048 - 0BD60050; 0BD80001 - 0BD80017, 0BD80023 - 0BD80042, 0BBX0011, 0BBX0013, 0BBX0016 - 18, 0BBX0020; 0BD80047 - 0BD80050; ABDZ0001 - ABDZ0020; ABDZ0071 - ABDZ0080; ABDZ0027- ABDZ0070, ABDZ0081- ABDZ0086; ABE10023 - ABE10062; ABE 20008- ABE20026, ABE20028, ABE20036-ABE20055, ABE20065 - ABE20100; ABE50001 - ABE50004, ABE50019-ABE50058, ABE50080 - ABE50100; ABE90010 - ABE90050; ABEY0001-ABEY0012; ABEY0033- ABEY0052, ABEY0081- ABEY0100; ABF40001 - ABF40010, ABF40039- ABF40068, ABF40073 -ABF40092; ABF50020 - ABF50034; ABF60001 - ABF60015; ABFX0001 - ABFX0030, ABFX0042- ABFX0050; ABFY0001 , ABFY0013 - ABFY0052; ABFZ0049 - ABFZ0050; ABG20001 - ABG20018, ABG20026 - ABG20030; ABG30019-ABG30038; ABG60084 -ABG60113; ABG80003 - ABG80015; ABG80026- ABG80035; ABG80056-ABG80062; ABG60153- ABG60161; ABG80001, ABG80016- ABG80025; ABG80036 - ABG80055; ABG80066 - ABG80085, ABG80110- ABG80115; ABG90001 - ABG90019; ABG90038 - ABG90040; ABGX0001-ABGX0017, ABGX0029, ABGX0030, ABGZ0001- ABGZ0010; ABGZ0022 -ABGZ0051, ABGZ0055-ABGZ0060; ABH10001 - ABH10014; ABH20003 - ABH20030; ABH30001, ABH30002; ABH40032- ABH40035; ABH50001 -ABH50073; ABH60001-ABH60143; ABH60156- ABH60200; ABH70001-ABH70005, ABH70022 - ABH70051; ABH80002-ABH80032. - ;

Distribution pattern

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

device · product 7 of 8

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.

Z-0225-2019

Recall number: Z-0225-2019
Initiated: June 01, 2018
Classification: Class II
Status: Terminated
Recalling firm: Nakanishi Inc.
Quantity: 440

App-derived interpretation

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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 pattern

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

device · product 8 of 8

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.

Z-0226-2019

Recall number: Z-0226-2019
Initiated: June 01, 2018
Classification: Class II
Status: Terminated
Recalling firm: Nakanishi Inc.
Quantity: 1878

App-derived interpretation

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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 pattern

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

Event 80713

Event summary

Source snapshots represented here

Every recalled product in this event

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

Code information

Distribution pattern

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.

Reason for recall

Code information

Distribution pattern

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.

Reason for recall

Code information

Distribution pattern

Surgical Handpiece, Model: SGA-E2G Order Code: H184, 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

Code information

Distribution pattern

Micro Surgery Handpiece SGS, Model: SGS-ES, Order Code: H264, 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.

Reason for recall

Code information

Distribution pattern

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..

Reason for recall

Code information

Distribution pattern

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.

Reason for recall

Code information

Distribution pattern

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.

Reason for recall

Code information

Distribution pattern

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