Reported Oct 31, 2018 · Terminated
Micro Surgery Handpiece SGS, Model: SGS-ES, Order Code: H264, Manufactured by: Nakanishi Inc. The SGS/SGA Surgical…
Nakanishi Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Nakanishi Inc. · 700 · Kanuma, N/A · N/A
Is this the product you have?
- Micro Surgery Handpiece SGS
- ModelSGS-ES
- Order CodeH264
- Manufactured byNakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. Typical
- usage includes dental implant usedrilling and tapping the maxilla and mandible
- Lot codes and dates
- Previous Operation Manuals
OM-SH0015E002OM-SH0015E003OM-SH0015E004OM-SH0015E005OM-SH0100F
- OM-SH0096S Model NameSGS-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 -
- Previous Operation Manuals
- Amount recalled
- 2419
This recall covers 8 products
The agency filed one notice per product. You are reading one of them; the other 7 are below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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