Z-0224-2019 Class II Terminated
FDA device recall Z-0224-2019 was initiated by Nakanishi Inc. on June 1, 2018 and is designated Class II. 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 manual… The recall status is terminated (terminated April 28, 2021). Affected quantity: 1662.
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
- 1662
Product Description
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
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 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. - ;