Reported Jul 10, 2013 · Terminated
Acorn Bur, Long, For Use With TPS Universal Drill, Long "AM" Attachment Head
Surgical Instrument Service And Savings, 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: Surgical Instrument Service And Savings, Inc. · 2747 Sw 6th St · Redmond, OR · 97756-7109
Is this the product you have?
Acorn Bur, Long, For Use With TPS Universal Drill, Long "AM" Attachment Head
14 of 14 products
| Model / number | Product as published |
|---|---|
310.221 | Lot 122665 - Cannulated Drill Bit, for 3.0mm Cannulated Screws, 1.2mm Cannulation, Quick Coupling 2.0mm x 150mm |
310.288 | Lot 122289 - Drill Bit, For Modular Hand System, Quick Coupling 2.8mm x 165mm |
DB-2.5 | Lot 122322 - Drill Bit, Quick Coupling (Gold) 2.5mm |
1608-2-35 | Lot 122289, 122322 - Egg Micro Bur, 10 Flute, Stainless Steel 4.0mm |
5092-136 | Lot 122429, 122347 - Hall Micro Bur, Oval, Long, 8-Flute, Carbide 4.0mm x 8.0mm |
1608-2-11 | Lot 123353 - Micro Bur, Round, Stainless Steel 3.2mm |
227-10-62 | Lot 122447, 122347 - Oval Bur, Fast Cutting, 8-Flutes, Carbide, 44.5mm Total Length, 18.6mm Exposure 4.0mm x 7.9mm |
5300-10-901 | Lot 122411 - Oval Bur, Solid, 8-Flute, Medium, Head Length: 7.7mm, Carbide 4.0mm x 48mm |
5091-136 | Lot 122647 - Oval Cutting Carbide Bur, Medium, (8-Flute) 4.0mm |
5300-10-511 | Lot 123353, 122454 - Round Bur, Medium, Solid 8-Flute, Carbide 4.0mm x 48.3mm |
1608-2-9 | Lot 122665 - Round Bur, Micro, 8-Flute, Exposure: 28.2mm Stainless Steel 2.4mm x 54mm |
310.25 | Lot 122447 - Twist Drill, Quick Coupling 110mm 2.5mm |
1608-2-59 | Lot 122289, 122322 - Wire Pass Drill Bit 1.5mm |
| — | Lot 122511 Surgical instrument motors and accessories/attachments |
- Lot codes and dates
122347122454122411122289123353122429122322122447122665122647122511
- Amount recalled
- 30
This recall covers 22 products
The agency filed one notice per product. You are reading one of them; the other 21 are below.
9 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.
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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