Reported Oct 31, 2018 · Terminated
Micro Surgery Handpiece SGA, Model SGA-E2S Order Code: H265, 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 SGA
- Model SGA-E2S Order CodeH265
- 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
57 of 57 products
Products covered by this recall # Product as published 1 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 2 ABB60001, ABB60041-ABB60050, ABB60052-ABB60054, ALZ00064-ALZ00073 3 ABB10028, ABB10031-ABB10078, ABB20002, ABB20016, ABB20023-ABB20044 4 ABB30001-ABB30015,ABB30021-ABB30053 5 ABB40001-ABB40012, ABB40023-ABB40025 6 ABB50001-ABB50022, ABB50029-ABB50049 7 ABB60001, ABB60018-ABB60025, ABB60026-ABB60050, ABB60052-ABB60068, ABB60075-ABB60101 8 ABB90001-ABB90017, ABB90023-ABB90032, ABB90034-ABB90050, ABBX0001-ABBX0008, ABBX0011-ABBX0025, ABBX0032-ABBX0046 9 ABBZ0009-ABBZ0023 10 ABBY0012, ABBY0015-ABBY0018, ABBY0041-ABBY0050 11 ABBZ0029-ABBZ0050 12 ABC20001-ABC20008, ABC20024-ABC20050 13 ABC30001-ABC30043, ABC30049-ABC30050 14 ABC50001-ABC50010 15 ABC60001-ABC60043, ABC60053-ABC60092, ABC60095-ABC60100 16 ABC70001-ABC70034, ABC70043-ABC70092 17 ABC90005-ABC90114, ABC90119-ABC90149 18 ABCX0001-ABCX0019,ABCX0044-ABCX0100 19 ABCY0001-ABCY0003 20 ABCY0032-ABCY0041 - Amount recalled
- 1878
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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