Reported Oct 31, 2018 · Terminated
Micro Surgery Handpiece SGS, Model: SGS-E2S, Order Code: H266, 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-E2S
- Order CodeH266
- 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
65 of 65 products
Products covered by this recall # Product as published 1 Previous Operation Manuals:OM-SH0015E002, OM-SH0015E003,OM-SH0015E004, OM-SH0015E005, OM-SH0100F,OM-SH0096S. Model Name: SGS-E2S 2 Order Code H266 Serial Nos.:0LZ00004 -0LZ00013, 0LZ00015- 0LZ00018, 0LZ00021 - 0LZ00030, 0LZ00036 - 0LZ00040, 0LZ00043- 0LZ00054 3 0BB30001-0BB30010, 0BB30012 - 0BB30015 4 0LZ00058 5 0BB30022 - 0BB30026 6 0BB50001-0BB50013, 0BB50021 - 0BB50025 7 0BB70003 - 0BB70015 8 0BB90007-0BB90027 9 0BBX0001 - 0BBX0010 10 0BBY0001 - 0BBY0027, 0BBY0031 - 0BBY0035 11 0BBZ0017 - 0BBZ0026, 0BBZ0035 - 0BBZ0050 12 0BC30001 - 0BC30004 13 0BBZ0002 - 0BBZ0008 14 0BC30008 - 0BC30020 15 0BC50001 - 0BC50010 16 0BC60001- 0BC60004, 0BC60006 - 0BC60031, 0BC60036 - 0BC60050 17 0BC70001 - 0BC70015 18 0BC90006 - 0BC90025, 0BC90031 - 0BC90050, 0BC90054 -0BC90060 - 0BC90080 19 0BCX0001-0BCX0023 20 0BCY0003 - 0BCY0027 - Amount recalled
- 1662
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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